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CoRoent

Model 6850106 · Nuvasive, Inc. · DI 00887517376640

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

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

UDILibrary device dossier · generated 2026-09-06 · 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.

12342019-01: 0 reports for this device; peer average 1.33/device2019-02: 0 reports for this device; peer average 1.18/device2019-03: 0 reports for this device; peer average 1.85/device2019-04: 0 reports for this device; peer average 1.36/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.59/device2019-07: 0 reports for this device; peer average 1.6/device2019-08: 0 reports for this device; peer average 4.05/device2019-09: 0 reports for this device; peer average 1.44/device2019-10: 0 reports for this device; peer average 2.55/device2019-11: 0 reports for this device; peer average 1.18/device2019-12: 0 reports for this device; peer average 1.57/device2020-01: 0 reports for this device; peer average 3.94/device2020-02: 0 reports for this device; peer average 1.36/device2020-03: 0 reports for this device; peer average 1.4/device2020-04: 0 reports for this device; peer average 1.33/device2020-05: 0 reports for this device; peer average 1.35/device2020-06: 0 reports for this device; peer average 1.19/device2020-07: 0 reports for this device; peer average 2.09/device2020-08: 0 reports for this device; peer average 1.35/device2020-09: 0 reports for this device; peer average 1.71/device2020-10: 0 reports for this device; peer average 1.64/device2020-11: 0 reports for this device; peer average 1.14/device2020-12: 0 reports for this device; peer average 1.57/device2021-01: 0 reports for this device; peer average 1.29/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.71/device2021-04: 0 reports for this device; peer average 1.26/device2021-05: 0 reports for this device; peer average 2.25/device2021-06: 0 reports for this device; peer average 3.24/device2021-07: 0 reports for this device; peer average 1.44/device2021-08: 0 reports for this device; peer average 1.58/device2021-09: 0 reports for this device; peer average 1.59/device2021-10: 0 reports for this device; peer average 1.44/device2021-11: 0 reports for this device; peer average 1.24/device2021-12: 0 reports for this device; peer average 1.51/device2022-01: 0 reports for this device; peer average 1.32/device2022-02: 0 reports for this device; peer average 1.54/device2022-03: 0 reports for this device; peer average 1.58/device2022-04: 0 reports for this device; peer average 1.33/device2022-05: 0 reports for this device; peer average 1.7/device2022-06: 0 reports for this device; peer average 1.64/device2022-07: 0 reports for this device; peer average 1.33/device2022-08: 0 reports for this device; peer average 1.32/device2022-09: 0 reports for this device; peer average 2.14/device2022-10: 0 reports for this device; peer average 1.43/device2022-11: 0 reports for this device; peer average 1.64/device2022-12: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 2.67/device2023-02: 0 reports for this device; peer average 1.65/device2023-03: 0 reports for this device; peer average 2.56/device2023-04: 0 reports for this device; peer average 1.33/device2023-05: 0 reports for this device; peer average 1.36/device2023-06: 0 reports for this device; peer average 1.27/device2023-07: 0 reports for this device; peer average 1.67/device2023-08: 0 reports for this device; peer average 2.86/device2023-09: 0 reports for this device; peer average 1.38/device2023-10: 0 reports for this device; peer average 1.73/device2023-11: 0 reports for this device; peer average 1.13/device2023-12: 0 reports for this device; peer average 1.38/device2024-01: 0 reports for this device; peer average 1.85/device2024-02: 0 reports for this device; peer average 1.64/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 1.57/device2024-05: 0 reports for this device; peer average 1.8/device2024-06: 0 reports for this device; peer average 2.33/device2024-07: 0 reports for this device; peer average 1.53/device2024-08: 0 reports for this device; peer average 1.31/device2024-09: 0 reports for this device; peer average 1.57/device2024-10: 0 reports for this device; peer average 1.33/device2024-11: 0 reports for this device; peer average 1.38/device2024-12: 0 reports for this device; peer average 1.5/device2025-01: 0 reports for this device; peer average 1.42/device2025-02: 0 reports for this device; peer average 1.85/device2025-03: 0 reports for this device; peer average 2.71/device2025-04: 0 reports for this device; peer average 1.76/device2025-05: 0 reports for this device; peer average 1.95/device2025-06: 0 reports for this device; peer average 1.74/device2025-07: 0 reports for this device; peer average 1.88/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.57/device2025-10: 0 reports for this device; peer average 1.54/device2025-11: 0 reports for this device; peer average 1.73/device2025-12: 0 reports for this device; peer average 1.56/device2026-01: 0 reports for this device; peer average 1.47/device2026-02: 0 reports for this device; peer average 1.38/device2026-03: 0 reports for this device; peer average 1.78/device2026-04: 0 reports for this device; peer average 1.55/device2026-05: 0 reports for this device; peer average 2.17/device2026-06: 0 reports for this device; peer average 2.42/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.33
2019-0201.18
2019-0301.85
2019-0401.36
2019-0501.56
2019-0601.59
2019-0701.6
2019-0804.05
2019-0901.44
2019-1002.55
2019-1101.18
2019-1201.57
2020-0103.94
2020-0201.36
2020-0301.4
2020-0401.33
2020-0501.35
2020-0601.19
2020-0702.09
2020-0801.35
2020-0901.71
2020-1001.64
2020-1101.14
2020-1201.57
2021-0101.29
2021-0202
2021-0301.71
2021-0401.26
2021-0502.25
2021-0603.24
2021-0701.44
2021-0801.58
2021-0901.59
2021-1001.44
2021-1101.24
2021-1201.51
2022-0101.32
2022-0201.54
2022-0301.58
2022-0401.33
2022-0501.7
2022-0601.64
2022-0701.33
2022-0801.32
2022-0902.14
2022-1001.43
2022-1101.64
2022-1201.5
2023-0102.67
2023-0201.65
2023-0302.56
2023-0401.33
2023-0501.36
2023-0601.27
2023-0701.67
2023-0802.86
2023-0901.38
2023-1001.73
2023-1101.13
2023-1201.38
2024-0101.85
2024-0201.64
2024-0301.88
2024-0401.57
2024-0501.8
2024-0602.33
2024-0701.53
2024-0801.31
2024-0901.57
2024-1001.33
2024-1101.38
2024-1201.5
2025-0101.42
2025-0201.85
2025-0302.71
2025-0401.76
2025-0501.95
2025-0601.74
2025-0701.88
2025-0801.61
2025-0901.57
2025-1001.54
2025-1101.73
2025-1201.56
2026-0101.47
2026-0201.38
2026-0301.78
2026-0401.55
2026-0502.17
2026-0602.42
This device (reports/month)Average device in MQP, ODP, OVE (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

K140003 — cites (transitively): K123206 (d1), K043479 (d2), P980048 (d2) — cited as predicate by K142050, K150362, K172676, K223731

K140921 — cited as predicate by K142299, K150362, K161442

K142050 — cites (transitively): K081611 (d1), K130177 (d1), K140003 (d1), K123206 (d2), K043479 (d3), P980048 (d3) — cited as predicate by K150362, K150521, K231735

K150362 — cites (transitively): K081611 (d1), K140003 (d1), K140921 (d1), K142050 (d1), K142264 (d1), K123206 (d2), K130177 (d2), K043479 (d3), P980048 (d3) — cited as predicate by K160125, K162138, K162587, K163491, K180674, K181435, K251080

K163491 — cites (transitively): K150362 (d1), K081611 (d2), K140003 (d2), K140921 (d2), K142050 (d2), K142264 (d2), K123206 (d3), K130177 (d3), K043479 (d4), P980048 (d4) — cited as predicate by K172676, K172888, K173030, K173115, K173324, K173347, K173722, K180675, K181483, K182284, K192582, K201506, K213980, K231735

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