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Model D1814378 · Nuvasive, Inc. · DI 00887517013255

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

257102019-01: 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 1.68/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 1.63/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 1.34/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.74/device2020-03: 0 reports for this device; peer average 1.43/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.63/device2020-06: 0 reports for this device; peer average 1.82/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.64/device2020-09: 0 reports for this device; peer average 2.52/device2020-10: 0 reports for this device; peer average 2.03/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 1.71/device2021-02: 0 reports for this device; peer average 1.74/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 1.73/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 1.85/device2021-12: 0 reports for this device; peer average 2.49/device2022-01: 0 reports for this device; peer average 3.1/device2022-02: 0 reports for this device; peer average 2.59/device2022-03: 0 reports for this device; peer average 1.76/device2022-04: 0 reports for this device; peer average 1.78/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 1.8/device2022-07: 0 reports for this device; peer average 2.25/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 1.79/device2022-10: 0 reports for this device; peer average 1.88/device2022-11: 0 reports for this device; peer average 1.94/device2022-12: 0 reports for this device; peer average 1.69/device2023-01: 0 reports for this device; peer average 2.39/device2023-02: 0 reports for this device; peer average 2.09/device2023-03: 0 reports for this device; peer average 1.72/device2023-04: 0 reports for this device; peer average 1.87/device2023-05: 0 reports for this device; peer average 2.04/device2023-06: 0 reports for this device; peer average 1.76/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.79/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.87/device2023-11: 0 reports for this device; peer average 9.8/device2023-12: 0 reports for this device; peer average 3.76/device2024-01: 0 reports for this device; peer average 1.95/device2024-02: 0 reports for this device; peer average 2.14/device2024-03: 0 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.38/device2024-05: 0 reports for this device; peer average 1.81/device2024-06: 0 reports for this device; peer average 1.85/device2024-07: 0 reports for this device; peer average 1.94/device2024-08: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 1.91/device2024-10: 0 reports for this device; peer average 2.19/device2024-11: 0 reports for this device; peer average 1.73/device2024-12: 0 reports for this device; peer average 1.78/device2025-01: 0 reports for this device; peer average 1.85/device2025-02: 0 reports for this device; peer average 1.71/device2025-03: 0 reports for this device; peer average 1.69/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.66/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 1.66/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 1.86/device2026-01: 0 reports for this device; peer average 1.89/device2026-02: 0 reports for this device; peer average 1.55/device2026-03: 0 reports for this device; peer average 2.75/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.58/device2026-06: 0 reports for this device; peer average 1.67/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
2019-0301.68
2019-0401.46
2019-0501.6
2019-0601.57
2019-0701.63
2019-0801.36
2019-0901.32
2019-1001.83
2019-1101.58
2019-1201.34
2020-0101.67
2020-0201.74
2020-0301.43
2020-0401.43
2020-0501.63
2020-0601.82
2020-0701.85
2020-0801.64
2020-0902.52
2020-1002.03
2020-1102.1
2020-1201.76
2021-0101.71
2021-0201.74
2021-0302
2021-0401.55
2021-0501.6
2021-0602.23
2021-0701.73
2021-0802.21
2021-0901.73
2021-1002.11
2021-1101.85
2021-1202.49
2022-0103.1
2022-0202.59
2022-0301.76
2022-0401.78
2022-0502.13
2022-0601.8
2022-0702.25
2022-0801.86
2022-0901.79
2022-1001.88
2022-1101.94
2022-1201.69
2023-0102.39
2023-0202.09
2023-0301.72
2023-0401.87
2023-0502.04
2023-0601.76
2023-0702.04
2023-0801.79
2023-0901.97
2023-1001.87
2023-1109.8
2023-1203.76
2024-0101.95
2024-0202.14
2024-0301.9
2024-0401.38
2024-0501.81
2024-0601.85
2024-0701.94
2024-0802.25
2024-0901.91
2024-1002.19
2024-1101.73
2024-1201.78
2025-0101.85
2025-0201.71
2025-0301.69
2025-0401.6
2025-0501.66
2025-0602.02
2025-0701.81
2025-0801.61
2025-0901.66
2025-1001.71
2025-1102.03
2025-1201.86
2026-0101.89
2026-0201.55
2026-0302.75
2026-0401.67
2026-0501.58
2026-0601.67
This device (reports/month)Average device in MAX, PHM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K193541 — cited as predicate by K201820, K203201, K250599

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