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CoRoent

Model 6161045 · Nuvasive, Inc. · DI 00887517291981

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080

MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060

ODP — Intervertebral Fusion Device With Bone Graft, Cervical · Class II · 21 CFR 888.3080

OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar · Class II · 21 CFR 888.3080

OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical · Class II · 21 CFR 888.3080

PHM — Intervertebral Fusion Device With Bone Graft, Thoracic · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

23562019-01: 0 reports for this device; peer average 1.47/device2019-02: 0 reports for this device; peer average 1.26/device2019-03: 0 reports for this device; peer average 1.74/device2019-04: 0 reports for this device; peer average 1.39/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.61/device2019-07: 0 reports for this device; peer average 1.6/device2019-08: 0 reports for this device; peer average 2.27/device2019-09: 0 reports for this device; peer average 1.61/device2019-10: 0 reports for this device; peer average 2.19/device2019-11: 0 reports for this device; peer average 1.45/device2019-12: 0 reports for this device; peer average 1.47/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 0 reports for this device; peer average 1.72/device2020-03: 0 reports for this device; peer average 1.47/device2020-04: 0 reports for this device; peer average 1.37/device2020-05: 0 reports for this device; peer average 1.48/device2020-06: 0 reports for this device; peer average 1.83/device2020-07: 0 reports for this device; peer average 2.18/device2020-08: 0 reports for this device; peer average 1.46/device2020-09: 0 reports for this device; peer average 2.44/device2020-10: 0 reports for this device; peer average 1.89/device2020-11: 0 reports for this device; peer average 1.93/device2020-12: 0 reports for this device; peer average 1.61/device2021-01: 0 reports for this device; peer average 1.58/device2021-02: 0 reports for this device; peer average 1.88/device2021-03: 0 reports for this device; peer average 1.85/device2021-04: 0 reports for this device; peer average 1.47/device2021-05: 0 reports for this device; peer average 2.11/device2021-06: 0 reports for this device; peer average 2.81/device2021-07: 0 reports for this device; peer average 1.67/device2021-08: 0 reports for this device; peer average 2.06/device2021-09: 0 reports for this device; peer average 1.69/device2021-10: 0 reports for this device; peer average 2.06/device2021-11: 0 reports for this device; peer average 1.73/device2021-12: 0 reports for this device; peer average 2.18/device2022-01: 0 reports for this device; peer average 2.47/device2022-02: 0 reports for this device; peer average 2.27/device2022-03: 0 reports for this device; peer average 1.71/device2022-04: 0 reports for this device; peer average 1.62/device2022-05: 0 reports for this device; peer average 2.04/device2022-06: 0 reports for this device; peer average 1.71/device2022-07: 0 reports for this device; peer average 1.84/device2022-08: 0 reports for this device; peer average 1.8/device2022-09: 0 reports for this device; peer average 1.98/device2022-10: 0 reports for this device; peer average 1.65/device2022-11: 0 reports for this device; peer average 1.81/device2022-12: 0 reports for this device; peer average 1.63/device2023-01: 0 reports for this device; peer average 2.33/device2023-02: 0 reports for this device; peer average 1.9/device2023-03: 0 reports for this device; peer average 2.04/device2023-04: 0 reports for this device; peer average 1.77/device2023-05: 0 reports for this device; peer average 1.66/device2023-06: 0 reports for this device; peer average 1.56/device2023-07: 0 reports for this device; peer average 1.93/device2023-08: 0 reports for this device; peer average 2.14/device2023-09: 0 reports for this device; peer average 1.79/device2023-10: 0 reports for this device; peer average 1.75/device2023-11: 0 reports for this device; peer average 6.46/device2023-12: 0 reports for this device; peer average 2.61/device2024-01: 0 reports for this device; peer average 1.93/device2024-02: 0 reports for this device; peer average 1.98/device2024-03: 0 reports for this device; peer average 1.86/device2024-04: 0 reports for this device; peer average 1.51/device2024-05: 0 reports for this device; peer average 1.87/device2024-06: 0 reports for this device; peer average 2.02/device2024-07: 0 reports for this device; peer average 1.83/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 1.8/device2024-10: 0 reports for this device; peer average 1.9/device2024-11: 0 reports for this device; peer average 1.63/device2024-12: 0 reports for this device; peer average 1.75/device2025-01: 0 reports for this device; peer average 1.68/device2025-02: 0 reports for this device; peer average 1.72/device2025-03: 0 reports for this device; peer average 1.98/device2025-04: 0 reports for this device; peer average 1.64/device2025-05: 0 reports for this device; peer average 1.78/device2025-06: 0 reports for this device; peer average 1.89/device2025-07: 0 reports for this device; peer average 1.92/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.68/device2025-10: 0 reports for this device; peer average 1.65/device2025-11: 0 reports for this device; peer average 1.83/device2025-12: 0 reports for this device; peer average 1.75/device2026-01: 0 reports for this device; peer average 1.66/device2026-02: 0 reports for this device; peer average 1.48/device2026-03: 0 reports for this device; peer average 2.29/device2026-04: 0 reports for this device; peer average 1.63/device2026-05: 0 reports for this device; peer average 1.77/device2026-06: 0 reports for this device; peer average 1.96/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.47
2019-0201.26
2019-0301.74
2019-0401.39
2019-0501.56
2019-0601.61
2019-0701.6
2019-0802.27
2019-0901.61
2019-1002.19
2019-1101.45
2019-1201.47
2020-0102.55
2020-0201.72
2020-0301.47
2020-0401.37
2020-0501.48
2020-0601.83
2020-0702.18
2020-0801.46
2020-0902.44
2020-1001.89
2020-1101.93
2020-1201.61
2021-0101.58
2021-0201.88
2021-0301.85
2021-0401.47
2021-0502.11
2021-0602.81
2021-0701.67
2021-0802.06
2021-0901.69
2021-1002.06
2021-1101.73
2021-1202.18
2022-0102.47
2022-0202.27
2022-0301.71
2022-0401.62
2022-0502.04
2022-0601.71
2022-0701.84
2022-0801.8
2022-0901.98
2022-1001.65
2022-1101.81
2022-1201.63
2023-0102.33
2023-0201.9
2023-0302.04
2023-0401.77
2023-0501.66
2023-0601.56
2023-0701.93
2023-0802.14
2023-0901.79
2023-1001.75
2023-1106.46
2023-1202.61
2024-0101.93
2024-0201.98
2024-0301.86
2024-0401.51
2024-0501.87
2024-0602.02
2024-0701.83
2024-0801.83
2024-0901.8
2024-1001.9
2024-1101.63
2024-1201.75
2025-0101.68
2025-0201.72
2025-0301.98
2025-0401.64
2025-0501.78
2025-0601.89
2025-0701.92
2025-0801.61
2025-0901.68
2025-1001.65
2025-1101.83
2025-1201.75
2026-0101.66
2026-0201.48
2026-0302.29
2026-0401.63
2026-0501.77
2026-0601.96
This device (reports/month)Average device in MAX, MQP, ODP, OVD, OVE, PHM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K081611 — cited as predicate by K142050, K150362, K150954, K151651, K161442, K162138, K172676, K180550

K140659 — cited as predicate by K141896, K150994

K141665 — cites (transitively): K071795 (d1), K080699 (d1), K090816 (d1), K113348 (d1), K120918 (d1), K123045 (d1), K123231 (d1), K130820 (d1), K131082 (d1), K132601 (d1), K133455 (d1), K140319 (d1), K031635 (d2), K080568 (d2), K081917 (d2), K101923 (d2), K080537 (d2), K023570 (d2), K062933 (d2), K072791 (d2), K073291 (d2), K082310 (d2), K091278 (d2), K092193 (d2), K100042 (d2), P960025 (d2), K130548 (d2), K043206 (d2), K133623 (d2), K110632 (d2), K122967 (d2), K043479 (d3), P950002 (d3), P950019 (d3), P970015 (d3), K071724 (d3), K073348 (d3), K092901 (d3), K082262 (d4) — cited as predicate by K143595, K150994, K151310, K151322, K151472, K153627, K153782, K153786, K161223, K163230, K171151, K171633, K172009, K172341, K173182, K181860, K203201

K141896 — cites (transitively): K071795 (d1), K120918 (d1), K123027 (d1), K132601 (d1), K140659 (d1), K082732 (d2), K130548 (d2), K092901 (d3), K082262 (d4), P950002 (d4), P950019 (d4), P960025 (d4) — cited as predicate by K151472, K161230

K150994 — cites (transitively): K140659 (d1), K141665 (d1), K071795 (d2), K080699 (d2), K090816 (d2), K113348 (d2), K120918 (d2), K123045 (d2), K123231 (d2), K130820 (d2), K131082 (d2), K132601 (d2), K133455 (d2), K140319 (d2), K031635 (d3), K080568 (d3), K081917 (d3), K101923 (d3), K080537 (d3), K023570 (d3), K062933 (d3), K072791 (d3), K073291 (d3), K082310 (d3), K091278 (d3), K092193 (d3), K100042 (d3), P960025 (d3), K130548 (d3), K043206 (d3), K133623 (d3), K110632 (d3), K122967 (d3), K043479 (d4), P950002 (d4), P950019 (d4), P970015 (d4), K071724 (d4), K073348 (d4), K092901 (d4), K082262 (d5) — cited as predicate by K153419, K160958

K151472 — cites (transitively): K141665 (d1), K141896 (d1), K071795 (d2), K080699 (d2), K090816 (d2), K113348 (d2), K120918 (d2), K123045 (d2), K123231 (d2), K130820 (d2), K131082 (d2), K132601 (d2), K133455 (d2), K140319 (d2), K123027 (d2), K140659 (d2), K031635 (d3), K080568 (d3), K081917 (d3), K101923 (d3), K082732 (d3), K080537 (d3), K023570 (d3), K062933 (d3), K072791 (d3), K073291 (d3), K082310 (d3), K091278 (d3), K092193 (d3), K100042 (d3), P960025 (d3), K130548 (d3), K043206 (d3), K133623 (d3), K110632 (d3), K122967 (d3), K043479 (d4), P950002 (d4), P950019 (d4), P970015 (d4), K071724 (d4), K073348 (d4), K092901 (d4), K082262 (d5) — cited as predicate by K143479, K151310, K153419, K162327, K250186

K153419 — cites (transitively): K150994 (d1), K151472 (d1), K140659 (d2), K141665 (d2), K141896 (d2), K071795 (d3), K080699 (d3), K090816 (d3), K113348 (d3), K120918 (d3), K123045 (d3), K123231 (d3), K130820 (d3), K131082 (d3), K132601 (d3), K133455 (d3), K140319 (d3), K123027 (d3), K031635 (d4), K080568 (d4), K081917 (d4), K101923 (d4), K082732 (d4), K080537 (d4), K023570 (d4), K062933 (d4), K072791 (d4), K073291 (d4), K082310 (d4), K091278 (d4), K092193 (d4), K100042 (d4), P960025 (d4), K130548 (d4), K043206 (d4), K133623 (d4), K110632 (d4), K122967 (d4), K043479 (d5), P950002 (d5), P950019 (d5), P970015 (d5), K071724 (d5), K073348 (d5), K092901 (d5), K082262 (d6) — cited as predicate by K160051, K161230, K170962, K171434, K201820, K203201

K161230 — cites (transitively): K141896 (d1), K153419 (d1), K153782 (d1), K160051 (d1), K071795 (d2), K120918 (d2), K123027 (d2), K132601 (d2), K140659 (d2), K150994 (d2), K151472 (d2), K100043 (d2), K123045 (d2), K131723 (d2), K140319 (d2), K140479 (d2), K141665 (d2), K143163 (d2), K082732 (d3), K130548 (d3), K110632 (d3), K113348 (d3), K122967 (d3), K103382 (d3), K080699 (d3), K090816 (d3), K123231 (d3), K130820 (d3), K131082 (d3), K133455 (d3), K083661 (d3), K093704 (d3), K093864 (d3), K100865 (d3), K101051 (d3), K120869 (d3), K133328 (d3), K141217 (d3), K090166 (d4), P960025 (d4), K073470 (d4), K080758 (d4), K082014 (d4), K093242 (d4), K082252 (d4), K071724 (d4), K073348 (d4), K031635 (d4), K080568 (d4), K081917 (d4), K101923 (d4), K080537 (d4), K092901 (d4), K023570 (d4), K062933 (d4), K072791 (d4), K073291 (d4), K082310 (d4), K091278 (d4), K092193 (d4), K100042 (d4), K043206 (d4), K133623 (d4), K082262 (d5), P950002 (d5), P950019 (d5), K043479 (d5), P970015 (d5) — cited as predicate by K163230, K170119, K170962, K171633, K172123, K173892, K181386, K192026, K192760, K193593, K201820, K203201, K220478

K170962 — cites (transitively): K120918 (d1), K153419 (d1), K161230 (d1), K071795 (d2), K150994 (d2), K151472 (d2), K141896 (d2), K153782 (d2), K160051 (d2), K123027 (d3), K132601 (d3), K140659 (d3), K141665 (d3), K100043 (d3), K123045 (d3), K131723 (d3), K140319 (d3), K140479 (d3), K143163 (d3), K082732 (d4), K130548 (d4), K110632 (d4), K113348 (d4), K122967 (d4), K103382 (d4), K080699 (d4), K090816 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K133455 (d4), K083661 (d4), K093704 (d4), K093864 (d4), K100865 (d4), K101051 (d4), K120869 (d4), K133328 (d4), K141217 (d4), K090166 (d5), P960025 (d5), K073470 (d5), K080758 (d5), K082014 (d5), K093242 (d5), K082252 (d5), K071724 (d5), K073348 (d5), K031635 (d5), K080568 (d5), K081917 (d5), K101923 (d5), K080537 (d5), K092901 (d5), K023570 (d5), K062933 (d5), K072791 (d5), K073291 (d5), K082310 (d5), K091278 (d5), K092193 (d5), K100042 (d5), K043206 (d5), K133623 (d5), K082262 (d6), P950002 (d6), P950019 (d6), K043479 (d6), P970015 (d6) — cited as predicate by K171633, K172123, K172341, K173025, K173153, K181357, K181453, K181860, K200953, K201820, K203201

K231735 — cites (transitively): K142050 (d1), K162138 (d1), K163491 (d1), K170961 (d1), K173030 (d1), K192582 (d1), K203714 (d1), K223731 (d1), K081611 (d2), K130177 (d2), K140003 (d2), K140319 (d2), K150362 (d2), K160916 (d2), K143685 (d2), K131025 (d2), K142299 (d2), K150053 (d2), K100089 (d2), K151276 (d2), K191974 (d2), K200953 (d2), K201692 (d2), K201820 (d2), K163230 (d2), K172676 (d2), K222276 (d2), K000536 (d3), K053581 (d3), K123206 (d3), K071795 (d3), K110632 (d3), K113348 (d3), K122967 (d3), K132601 (d3), K092521 (d3), K102547 (d3), K132894 (d3), K140921 (d3), K133218 (d3), K142264 (d3), K153782 (d3), K141665 (d3), K150481 (d3), K152304 (d3), K161230 (d3), K120603 (d3), K061499 (d3), K080736 (d3), K090641 (d3), K151584 (d3), K100043 (d3), K153105 (d3), K170962 (d3), K181860 (d3), K192760 (d3), K153419 (d3), K163506 (d3), K170592 (d3), K172341 (d3), K173153 (d3), K181386 (d3), K193541 (d3), K193593 (d3), K170306 (d3), K201605 (d3), K071724 (d4), K073348 (d4), K031635 (d4), K080568 (d4), K081917 (d4), K101923 (d4), K111123 (d4), P980048 (d4), K043479 (d4), K130548 (d4), K073351 (d4), K103033 (d4), K111119 (d4), K112388 (d4), K120345 (d4), K071833 (d4), K112036 (d4), K122771 (d4), K080699 (d4), K090816 (d4), K120918 (d4), K123045 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K133455 (d4), K082698 (d4), K100945 (d4), K110843 (d4), K112316 (d4), K113138 (d4), K113561 (d4), K130699 (d4), K133614 (d4), K141405 (d4), K060506 (d4), K123486 (d4), K132624 (d4), K143393 (d4), K143616 (d4), K140770 (d4), K151374 (d4), K150994 (d4), K151472 (d4), K131723 (d4), K140479 (d4), K143163 (d4), K141896 (d4), K160051 (d4), K140348 (d4), K151128 (d4), K151322 (d4), K060728 (d4), K080009 (d4), K101860 (d4), K110368 (d4), K112773 (d4), K132805 (d4), K141956 (d4), K143533 (d4), K151154 (d4), K171633 (d4), K172123 (d4), K152943 (d4), K172888 (d4), K181644 (d4), K183447 (d4), K080401 (d5), K082672 (d5), K070754 (d5), P000028 (d5), K051454 (d5), K063399 (d5), K080024 (d5), K091088 (d5), K083626 (d5), K083894 (d5), P960025 (d5), K083389 (d5), K094042 (d5), K073202 (d5), K042571 (d5), K050624 (d5), K061836 (d5), K062132 (d5), K082014 (d5), K080537 (d5), K072160 (d5), K092901 (d5), K031672 (d5), K103169 (d5), K023570 (d5), K062933 (d5), K072791 (d5), K073291 (d5), K082310 (d5), K091278 (d5), K092193 (d5), K100042 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K043206 (d5), K133623 (d5), K101302 (d5), K123969 (d5), K132738 (d5), K133126 (d5), K133340 (d5), K103382 (d5), K081968 (d5), K131372 (d5), K123027 (d5), K140659 (d5), K083661 (d5), K093704 (d5), K093864 (d5), K100865 (d5), K101051 (d5), K120869 (d5), K133328 (d5), K141217 (d5), K053340 (d5), K100391 (d5), K133577 (d5), K133650 (d5), K052494 (d5), K081614 (d5), K140162 (d5), K143126 (d5), K073109 (d5), K151214 (d5), K153627 (d5), K143065 (d5), K170503 (d5), K161888 (d5), K181014 (d5), P950002 (d6), K082262 (d6), P950019 (d6), K090166 (d6), P970015 (d6), K042871 (d6), K052888 (d6), K073470 (d6), K080758 (d6), K093242 (d6), K082252 (d6), K082732 (d6), K050539 (d6), K063423 (d6), K974556 (d6), K080822 (d6), K090064 (d6), K090566 (d6), K121693 (d6), K073669 (d6), K090899 (d6), K100305 (d6), K111166 (d6), K083026 (d6), K100175 (d6), K112405 (d6), K113528 (d6), K122591 (d6), K132897 (d6), K121760 (d6), K021039 (d6), K040130 (d6), K072339 (d6), K072943 (d6), K090415 (d6), K121837 (d6), K142095 (d6), K141942 (d6), K143595 (d6), K141135 (d6), K080588 (d6), K093669 (d6), K112095 (d6), K122588 (d6), K143258 (d6), K160955 (d6), K052533 (d7), K080349 (d7), K102293 (d7), K090353 (d7), K120368 (d7), K081888 (d7), K102067 (d7), K103666 (d7), K133557 (d7), K101301 (d7), K101310 (d7), K102090 (d7), K111122 (d7), K133200 (d7), K133286 (d7), K140106 (d7), K103111 (d7), K083714 (d8), K072970 (d8), K052210 (d8), K083186 (d8), K033926 (d8), K094025 (d8), K103731 (d8), K072415 (d8) — cited as predicate by K240830, K241375, K253876

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Nuvasive, Inc.

  • Warning Letter 2013-03-12 NuVasive Inc
  • Warning Letter 2013-03-12 NuVasive Inc
  • VAI 2024-05-06 NuVasive Specialized Orthopedics, Inc. · 12 citations
  • NAI 2024-01-18 Nuvasive PR, Inc. · 0 citations
  • NAI 2019-12-09 Nuvasive PR, Inc. · 0 citations
  • NAI 2019-07-29 NuVasive, Inc · 0 citations
  • NAI 2017-05-31 Nuvasive PR, Inc. · 0 citations
  • VAI 2017-05-26 NuVasive Inc · 2 citations
  • VAI 2017-05-26 NuVasive Inc · 2 citations
  • VAI 2017-05-04 NuVasive, Inc · 3 citations
  • VAI 2016-10-26 Nuvasive Inc · 2 citations
  • NAI 2014-11-19 NuVasive Inc · 0 citations
  • NAI 2014-11-19 NuVasive Inc · 0 citations
  • NAI 2014-08-27 Nuvasive Inc · 4 citations
  • NAI 2014-04-01 Nuvasive PR, Inc. · 0 citations
  • NAI 2014-02-20 NuVasive Specialized Orthopedics, Inc. · 0 citations
  • NAI 2014-02-05 NuVasive Inc · 0 citations
  • NAI 2014-02-05 NuVasive Inc · 0 citations
  • OAI 2012-11-02 NuVasive Inc · 0 citations
  • OAI 2012-11-02 NuVasive Inc · 0 citations
  • NAI 2012-02-10 NuVasive Inc · 0 citations
  • NAI 2012-02-10 NuVasive Inc · 0 citations