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MLX

Model 8083828 · Nuvasive, Inc. · DI 00887517268129

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 (2)

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.

Malfunction: 2

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: 2 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
2023-1021.87
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

K130820 — cited as predicate by K140162, K141665, K153105

K140770 — cited as predicate by K143595, K151374, K153105, K153627, K171633, K173892

K151374 — cites (transitively): K140162 (d1), K140770 (d1), K143126 (d1), K130820 (d2), K132601 (d2), K133614 (d2), K142095 (d2), P950019 (d2), P960025 (d2), K130548 (d3), K082698 (d3), K101302 (d3), K103169 (d3), K140106 (d3), K081917 (d4), K092901 (d4), K082262 (d5), P950002 (d5) — cited as predicate by K153105, K190418

K153105 — cites (transitively): K120918 (d1), K130820 (d1), K140770 (d1), K151374 (d1), K071795 (d2), K140162 (d2), K143126 (d2), K132601 (d3), K133614 (d3), K142095 (d3), P950019 (d3), P960025 (d3), K130548 (d4), K082698 (d4), K101302 (d4), K103169 (d4), K140106 (d4), K081917 (d5), K092901 (d5), K082262 (d6), P950002 (d6) — cited as predicate by K172123, K173025, K200953

K173025 — cites (transitively): K140162 (d1), K153105 (d1), K170962 (d1), K130820 (d2), K132601 (d2), K120918 (d2), K140770 (d2), K151374 (d2), K153419 (d2), K161230 (d2), K071795 (d3), K130548 (d3), K143126 (d3), K150994 (d3), K151472 (d3), K141896 (d3), K153782 (d3), K160051 (d3), K092901 (d4), K123027 (d4), K140659 (d4), K133614 (d4), K142095 (d4), P950019 (d4), P960025 (d4), K141665 (d4), K100043 (d4), K123045 (d4), K131723 (d4), K140319 (d4), K140479 (d4), K143163 (d4), K082262 (d5), P950002 (d5), K082732 (d5), K082698 (d5), K101302 (d5), K103169 (d5), K110632 (d5), K113348 (d5), K122967 (d5), K103382 (d5), K080699 (d5), K090816 (d5), K123231 (d5), K131082 (d5), K133455 (d5), K140106 (d5), K083661 (d5), K093704 (d5), K093864 (d5), K100865 (d5), K101051 (d5), K120869 (d5), K133328 (d5), K141217 (d5), K090166 (d6), K073470 (d6), K080758 (d6), K082014 (d6), K093242 (d6), K081917 (d6), K082252 (d6), K071724 (d6), K073348 (d6), K031635 (d6), K080568 (d6), K101923 (d6), K080537 (d6), K023570 (d6), K062933 (d6), K072791 (d6), K073291 (d6), K082310 (d6), K091278 (d6), K092193 (d6), K100042 (d6), K043206 (d6), K133623 (d6), K043479 (d7), P970015 (d7) — cited as predicate by K203038, K211474

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