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Brigade

Model 6951442 · Nuvasive, Inc. · DI 00887517400444

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

OVD — Intervertebral Fusion Device With Integrated Fixation, 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.

24572019-01: 0 reports for this device; peer average 1.57/device2019-02: 0 reports for this device; peer average 1.32/device2019-03: 0 reports for this device; peer average 1.78/device2019-04: 0 reports for this device; peer average 1.37/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.69/device2019-07: 0 reports for this device; peer average 1.57/device2019-08: 0 reports for this device; peer average 1.38/device2019-09: 0 reports for this device; peer average 1.62/device2019-10: 0 reports for this device; peer average 1.89/device2019-11: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1.49/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.75/device2020-03: 0 reports for this device; peer average 1.51/device2020-04: 0 reports for this device; peer average 1.37/device2020-05: 0 reports for this device; peer average 1.49/device2020-06: 0 reports for this device; peer average 1.96/device2020-07: 0 reports for this device; peer average 2.29/device2020-08: 0 reports for this device; peer average 1.55/device2020-09: 0 reports for this device; peer average 2.48/device2020-10: 0 reports for this device; peer average 1.99/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1.59/device2021-01: 0 reports for this device; peer average 1.64/device2021-02: 0 reports for this device; peer average 1.61/device2021-03: 0 reports for this device; peer average 1.9/device2021-04: 0 reports for this device; peer average 1.59/device2021-05: 0 reports for this device; peer average 1.79/device2021-06: 0 reports for this device; peer average 2.45/device2021-07: 0 reports for this device; peer average 1.75/device2021-08: 0 reports for this device; peer average 2.13/device2021-09: 0 reports for this device; peer average 1.67/device2021-10: 0 reports for this device; peer average 2.16/device2021-11: 0 reports for this device; peer average 1.83/device2021-12: 0 reports for this device; peer average 2.36/device2022-01: 0 reports for this device; peer average 2.72/device2022-02: 0 reports for this device; peer average 2.42/device2022-03: 0 reports for this device; peer average 1.77/device2022-04: 0 reports for this device; peer average 1.74/device2022-05: 0 reports for this device; peer average 2.18/device2022-06: 0 reports for this device; peer average 1.72/device2022-07: 0 reports for this device; peer average 1.95/device2022-08: 0 reports for this device; peer average 1.94/device2022-09: 0 reports for this device; peer average 1.95/device2022-10: 0 reports for this device; peer average 1.71/device2022-11: 0 reports for this device; peer average 1.85/device2022-12: 0 reports for this device; peer average 1.62/device2023-01: 0 reports for this device; peer average 2.25/device2023-02: 0 reports for this device; peer average 1.88/device2023-03: 0 reports for this device; peer average 1.92/device2023-04: 0 reports for this device; peer average 1.78/device2023-05: 0 reports for this device; peer average 1.73/device2023-06: 0 reports for this device; peer average 1.59/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.69/device2023-09: 0 reports for this device; peer average 1.85/device2023-10: 0 reports for this device; peer average 1.72/device2023-11: 0 reports for this device; peer average 7.17/device2023-12: 0 reports for this device; peer average 2.85/device2024-01: 0 reports for this device; peer average 1.86/device2024-02: 0 reports for this device; peer average 2.02/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 1.49/device2024-05: 0 reports for this device; peer average 1.83/device2024-06: 0 reports for this device; peer average 1.76/device2024-07: 0 reports for this device; peer average 1.88/device2024-08: 0 reports for this device; peer average 1.86/device2024-09: 0 reports for this device; peer average 1.82/device2024-10: 0 reports for this device; peer average 1.92/device2024-11: 0 reports for this device; peer average 1.69/device2024-12: 0 reports for this device; peer average 1.73/device2025-01: 0 reports for this device; peer average 1.71/device2025-02: 0 reports for this device; peer average 1.65/device2025-03: 0 reports for this device; peer average 1.97/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.84/device2025-06: 0 reports for this device; peer average 1.88/device2025-07: 0 reports for this device; peer average 1.83/device2025-08: 0 reports for this device; peer average 1.62/device2025-09: 0 reports for this device; peer average 1.65/device2025-10: 0 reports for this device; peer average 1.69/device2025-11: 0 reports for this device; peer average 1.8/device2025-12: 0 reports for this device; peer average 1.77/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 1.45/device2026-03: 0 reports for this device; peer average 2.42/device2026-04: 0 reports for this device; peer average 1.65/device2026-05: 0 reports for this device; peer average 1.59/device2026-06: 0 reports for this device; peer average 1.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.57
2019-0201.32
2019-0301.78
2019-0401.37
2019-0501.56
2019-0601.69
2019-0701.57
2019-0801.38
2019-0901.62
2019-1001.89
2019-1101.5
2019-1201.49
2020-0101.67
2020-0201.75
2020-0301.51
2020-0401.37
2020-0501.49
2020-0601.96
2020-0702.29
2020-0801.55
2020-0902.48
2020-1001.99
2020-1102
2020-1201.59
2021-0101.64
2021-0201.61
2021-0301.9
2021-0401.59
2021-0501.79
2021-0602.45
2021-0701.75
2021-0802.13
2021-0901.67
2021-1002.16
2021-1101.83
2021-1202.36
2022-0102.72
2022-0202.42
2022-0301.77
2022-0401.74
2022-0502.18
2022-0601.72
2022-0701.95
2022-0801.94
2022-0901.95
2022-1001.71
2022-1101.85
2022-1201.62
2023-0102.25
2023-0201.88
2023-0301.92
2023-0401.78
2023-0501.73
2023-0601.59
2023-0702
2023-0801.69
2023-0901.85
2023-1001.72
2023-1107.17
2023-1202.85
2024-0101.86
2024-0202.02
2024-0301.88
2024-0401.49
2024-0501.83
2024-0601.76
2024-0701.88
2024-0801.86
2024-0901.82
2024-1001.92
2024-1101.69
2024-1201.73
2025-0101.71
2025-0201.65
2025-0301.97
2025-0401.6
2025-0501.84
2025-0601.88
2025-0701.83
2025-0801.62
2025-0901.65
2025-1001.69
2025-1101.8
2025-1201.77
2026-0101.71
2026-0201.45
2026-0302.42
2026-0401.65
2026-0501.59
2026-0601.65
This device (reports/month)Average device in MAX, MQP, OVD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K100043 — cited as predicate by K111166, K112561, K150135, K151214, K151665, K153782, K160051, K181386, K200953

K123045 — cites (transitively): K071795 (d1) — cited as predicate by K140479, K141665, K141942, K142487, K143595, K150135, K151214, K152943, K153782, K160051, K160597, K161438, K163269, K171689, K181386, K181531, K192047, K211935

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

K181386 — cites (transitively): K100043 (d1), K123045 (d1), K161230 (d1), K071795 (d2), K141896 (d2), K153419 (d2), K153782 (d2), K160051 (d2), K120918 (d3), K123027 (d3), K132601 (d3), K140659 (d3), K150994 (d3), K151472 (d3), K131723 (d3), K140319 (d3), K140479 (d3), K141665 (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 K201087, K201820, K203201, K203278

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