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Tranquil-L™

Model 522887 · NEXUS SPINE, L.L.C. · DI B6785228870

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · 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.

358102019-01: 0 reports for this device; peer average 1.54/device2019-02: 0 reports for this device; peer average 1.22/device2019-03: 0 reports for this device; peer average 1.69/device2019-04: 0 reports for this device; peer average 1.46/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 1.65/device2019-08: 0 reports for this device; peer average 1.36/device2019-09: 0 reports for this device; peer average 1.32/device2019-10: 0 reports for this device; peer average 1.83/device2019-11: 0 reports for this device; peer average 1.58/device2019-12: 0 reports for this device; peer average 1.36/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.73/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.64/device2020-06: 0 reports for this device; peer average 1.84/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.63/device2020-09: 0 reports for this device; peer average 2.52/device2020-10: 0 reports for this device; peer average 2.05/device2020-11: 0 reports for this device; peer average 2.1/device2020-12: 0 reports for this device; peer average 1.76/device2021-01: 0 reports for this device; peer average 1.7/device2021-02: 0 reports for this device; peer average 1.72/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.55/device2021-05: 0 reports for this device; peer average 1.6/device2021-06: 0 reports for this device; peer average 2.23/device2021-07: 0 reports for this device; peer average 1.73/device2021-08: 0 reports for this device; peer average 2.21/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 1.84/device2021-12: 0 reports for this device; peer average 2.54/device2022-01: 0 reports for this device; peer average 3.14/device2022-02: 0 reports for this device; peer average 2.62/device2022-03: 0 reports for this device; peer average 1.78/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 1.79/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 1.78/device2022-10: 0 reports for this device; peer average 1.87/device2022-11: 0 reports for this device; peer average 1.93/device2022-12: 0 reports for this device; peer average 1.7/device2023-01: 0 reports for this device; peer average 2.44/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 1.71/device2023-04: 0 reports for this device; peer average 1.81/device2023-05: 0 reports for this device; peer average 2.04/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.73/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.85/device2023-11: 0 reports for this device; peer average 10.03/device2023-12: 0 reports for this device; peer average 3.95/device2024-01: 0 reports for this device; peer average 1.86/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.36/device2024-05: 0 reports for this device; peer average 1.58/device2024-06: 0 reports for this device; peer average 1.79/device2024-07: 0 reports for this device; peer average 1.93/device2024-08: 0 reports for this device; peer average 2.27/device2024-09: 0 reports for this device; peer average 1.9/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 1.74/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.85/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.66/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.65/device2025-06: 0 reports for this device; peer average 2.02/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.59/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 2.03/device2025-12: 0 reports for this device; peer average 1.85/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 2.76/device2026-04: 0 reports for this device; peer average 1.57/device2026-05: 0 reports for this device; peer average 1.58/device2026-06: 0 reports for this device; peer average 1.6/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.54
2019-0201.22
2019-0301.69
2019-0401.46
2019-0501.6
2019-0601.57
2019-0701.65
2019-0801.36
2019-0901.32
2019-1001.83
2019-1101.58
2019-1201.36
2020-0101.67
2020-0201.73
2020-0301.45
2020-0401.43
2020-0501.64
2020-0601.84
2020-0701.85
2020-0801.63
2020-0902.52
2020-1002.05
2020-1102.1
2020-1201.76
2021-0101.7
2021-0201.72
2021-0302
2021-0401.55
2021-0501.6
2021-0602.23
2021-0701.73
2021-0802.21
2021-0901.72
2021-1002.11
2021-1101.84
2021-1202.54
2022-0103.14
2022-0202.62
2022-0301.78
2022-0401.76
2022-0502.13
2022-0601.79
2022-0702.21
2022-0801.86
2022-0901.78
2022-1001.87
2022-1101.93
2022-1201.7
2023-0102.44
2023-0202.05
2023-0301.71
2023-0401.81
2023-0502.04
2023-0601.75
2023-0702.04
2023-0801.73
2023-0901.97
2023-1001.85
2023-11010.03
2023-1203.95
2024-0101.86
2024-0202.13
2024-0301.9
2024-0401.36
2024-0501.58
2024-0601.79
2024-0701.93
2024-0802.27
2024-0901.9
2024-1002.13
2024-1101.74
2024-1201.69
2025-0101.85
2025-0201.66
2025-0301.66
2025-0401.6
2025-0501.65
2025-0602.02
2025-0701.81
2025-0801.61
2025-0901.59
2025-1001.71
2025-1102.03
2025-1201.85
2026-0101.94
2026-0201.53
2026-0302.76
2026-0401.57
2026-0501.58
2026-0601.6
This device (reports/month)Average device in MAX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K170297 — cites (transitively): K071724 (d1), K073351 (d1), K081968 (d1), K083425 (d1), K090707 (d1), K091088 (d1), K092017 (d1), K130699 (d1), K160547 (d1), K031672 (d2), K082698 (d2), K103169 (d2), K110843 (d2), K150481 (d2), K081917 (d3), K101302 (d3), K051454 (d3), K063399 (d3), K080024 (d3), K080699 (d3), K100945 (d3), K112316 (d3), K113138 (d3), K113561 (d3), K133614 (d3), K141405 (d3), K080401 (d4), K083626 (d4), K083894 (d4), P960025 (d4), K073202 (d4), K100089 (d4), K131372 (d4), P950002 (d5), K090064 (d5) — cited as predicate by K181483, K181621, K181702, K233375, K240416

K181483 — cites (transitively): K163491 (d1), K170297 (d1), K170676 (d1), K172676 (d1), K172888 (d1), K173030 (d1), K173324 (d1), K150362 (d2), K071724 (d2), K073351 (d2), K081968 (d2), K083425 (d2), K090707 (d2), K091088 (d2), K092017 (d2), K130699 (d2), K160547 (d2), K072253 (d2), K072791 (d2), K081611 (d2), K120603 (d2), K140003 (d2), K162138 (d2), K163230 (d2), K170503 (d2), K143685 (d2), K142026 (d2), K160154 (d2), K111123 (d3), P980048 (d3), K031672 (d3), K082698 (d3), K103169 (d3), K110843 (d3), K123206 (d3), K090064 (d3), K110733 (d3), K113518 (d3), K133218 (d3), K140921 (d3), K142050 (d3), K142264 (d3), K100889 (d3), K150481 (d3), K140319 (d3), K160916 (d3), K141665 (d3), K152304 (d3), K161230 (d3), K080588 (d3), K092193 (d3), K093669 (d3), K112095 (d3), K122588 (d3), K143258 (d3), K082801 (d4), K081917 (d4), K101302 (d4), K082260 (d4), K051454 (d4), K063399 (d4), K080024 (d4), K080699 (d4), K102293 (d4), K043479 (d4), K071833 (d4), K112036 (d4), K122771 (d4), K071795 (d4), K110632 (d4), K113348 (d4), K122967 (d4), K132601 (d4), K090816 (d4), K120918 (d4), K123045 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K133455 (d4), K130177 (d4), K103111 (d4), K112316 (d4), K133614 (d4), K100945 (d4), K113138 (d4), K113561 (d4), K141405 (d4), K060506 (d4), K123486 (d4), K132624 (d4), K143393 (d4), K143616 (d4), K153782 (d4), K141896 (d4), K153419 (d4), K160051 (d4), K080401 (d5), K072970 (d5), K093242 (d5), K073202 (d5), K083626 (d5), P960025 (d5), K073348 (d5), K083894 (d5), K031635 (d5), K080568 (d5), K101923 (d5), K083389 (d5), K080537 (d5), K072160 (d5), K023570 (d5), K062933 (d5), K073291 (d5), K082310 (d5), K091278 (d5), K100042 (d5), K130548 (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), K100089 (d5), K131372 (d5), K123027 (d5), K140659 (d5), K053340 (d5), K100391 (d5), K150994 (d5), K151472 (d5), K100043 (d5), K131723 (d5), K140479 (d5), K143163 (d5), P950002 (d6), P950019 (d6), P970015 (d6), K042871 (d6), K052888 (d6), K082732 (d6), K050539 (d6), K063423 (d6), K974556 (d6), K092901 (d6), K103382 (d6), K083661 (d6), K093704 (d6), K093864 (d6), K100865 (d6), K101051 (d6), K120869 (d6), K133328 (d6), K141217 (d6), K082262 (d7), K090166 (d7), K073470 (d7), K080758 (d7), K082014 (d7), K082252 (d7) — cited as predicate by K200549, K233375, K240416

K181702 — cites (transitively): K092017 (d1), K122639 (d1), K170297 (d1), K170676 (d1), K081917 (d2), K090507 (d2), K071724 (d2), K073351 (d2), K081968 (d2), K083425 (d2), K090707 (d2), K091088 (d2), K130699 (d2), K160547 (d2), K072253 (d2), K072791 (d2), K031672 (d3), K082698 (d3), K103169 (d3), K110843 (d3), K150481 (d3), K101302 (d4), K051454 (d4), K063399 (d4), K080024 (d4), K080699 (d4), K100945 (d4), K112316 (d4), K113138 (d4), K113561 (d4), K133614 (d4), K141405 (d4), K080401 (d5), K083626 (d5), K083894 (d5), P960025 (d5), K073202 (d5), K100089 (d5), K131372 (d5), P950002 (d6), K090064 (d6) — cited as predicate by K212498, K233375

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

Manufacturer compliance record — NEXUS SPINE, L.L.C.

Nothing in the loaded window.