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X-CORE

Model 5963967 · Nuvasive, Inc. · DI 00887517270849

MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060

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 2/device2019-02: 0 reports for this device; peer average 1.38/device2019-03: 0 reports for this device; peer average 2.14/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.57/device2019-06: 0 reports for this device; peer average 2.14/device2019-07: 0 reports for this device; peer average 1.36/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.4/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.64/device2020-01: 0 reports for this device; peer average 1.57/device2020-02: 0 reports for this device; peer average 1.2/device2020-03: 0 reports for this device; peer average 1.43/device2020-04: 0 reports for this device; peer average 1.25/device2020-05: 0 reports for this device; peer average 1.2/device2020-06: 0 reports for this device; peer average 1.33/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 1.45/device2020-09: 0 reports for this device; peer average 1.62/device2020-10: 0 reports for this device; peer average 1.67/device2020-11: 0 reports for this device; peer average 1.13/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 0 reports for this device; peer average 1.31/device2021-02: 0 reports for this device; peer average 1.33/device2021-03: 0 reports for this device; peer average 1.78/device2021-04: 0 reports for this device; peer average 1.47/device2021-05: 0 reports for this device; peer average 1.29/device2021-06: 0 reports for this device; peer average 2.69/device2021-07: 0 reports for this device; peer average 1.58/device2021-08: 0 reports for this device; peer average 1.64/device2021-09: 0 reports for this device; peer average 1.38/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 1.44/device2021-12: 0 reports for this device; peer average 1.45/device2022-01: 0 reports for this device; peer average 1.38/device2022-02: 0 reports for this device; peer average 1.59/device2022-03: 0 reports for this device; peer average 1.67/device2022-04: 0 reports for this device; peer average 1.64/device2022-05: 0 reports for this device; peer average 1.79/device2022-06: 0 reports for this device; peer average 1.64/device2022-07: 0 reports for this device; peer average 1.44/device2022-08: 0 reports for this device; peer average 1.4/device2022-09: 0 reports for this device; peer average 2.29/device2022-10: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 1.8/device2022-12: 0 reports for this device; peer average 1.33/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1.17/device2023-05: 0 reports for this device; peer average 1.31/device2023-06: 0 reports for this device; peer average 1.25/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.63/device2023-09: 0 reports for this device; peer average 1.63/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 1.22/device2023-12: 0 reports for this device; peer average 1.37/device2024-01: 0 reports for this device; peer average 1.8/device2024-02: 0 reports for this device; peer average 1.75/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 2.25/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1.62/device2024-08: 0 reports for this device; peer average 1.07/device2024-09: 0 reports for this device; peer average 1.55/device2024-10: 0 reports for this device; peer average 1.29/device2024-11: 0 reports for this device; peer average 1.38/device2024-12: 0 reports for this device; peer average 1.47/device2025-01: 0 reports for this device; peer average 1.38/device2025-02: 0 reports for this device; peer average 1.75/device2025-03: 0 reports for this device; peer average 3.63/device2025-04: 0 reports for this device; peer average 1.67/device2025-05: 0 reports for this device; peer average 2.2/device2025-06: 0 reports for this device; peer average 1.54/device2025-07: 0 reports for this device; peer average 1.45/device2025-08: 0 reports for this device; peer average 1.71/device2025-09: 0 reports for this device; peer average 1.56/device2025-10: 0 reports for this device; peer average 1.56/device2025-11: 0 reports for this device; peer average 1.53/device2025-12: 0 reports for this device; peer average 1.57/device2026-01: 0 reports for this device; peer average 1.4/device2026-02: 0 reports for this device; peer average 1.18/device2026-03: 0 reports for this device; peer average 1.9/device2026-04: 0 reports for this device; peer average 1.8/device2026-05: 0 reports for this device; peer average 1.67/device2026-06: 0 reports for this device; peer average 1.75/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201.38
2019-0302.14
2019-0401
2019-0501.57
2019-0602.14
2019-0701.36
2019-0802
2019-0901
2019-1001.4
2019-1101
2019-1201.64
2020-0101.57
2020-0201.2
2020-0301.43
2020-0401.25
2020-0501.2
2020-0601.33
2020-0702.5
2020-0801.45
2020-0901.62
2020-1001.67
2020-1101.13
2020-1201.5
2021-0101.31
2021-0201.33
2021-0301.78
2021-0401.47
2021-0501.29
2021-0602.69
2021-0701.58
2021-0801.64
2021-0901.38
2021-1001.67
2021-1101.44
2021-1201.45
2022-0101.38
2022-0201.59
2022-0301.67
2022-0401.64
2022-0501.79
2022-0601.64
2022-0701.44
2022-0801.4
2022-0902.29
2022-1001.5
2022-1101.8
2022-1201.33
2023-0102
2023-0201.5
2023-0303
2023-0401.17
2023-0501.31
2023-0601.25
2023-0702
2023-0801.63
2023-0901.63
2023-1001.67
2023-1101.22
2023-1201.37
2024-0101.8
2024-0201.75
2024-0302
2024-0401.56
2024-0502.25
2024-0601.5
2024-0701.62
2024-0801.07
2024-0901.55
2024-1001.29
2024-1101.38
2024-1201.47
2025-0101.38
2025-0201.75
2025-0303.63
2025-0401.67
2025-0502.2
2025-0601.54
2025-0701.45
2025-0801.71
2025-0901.56
2025-1001.56
2025-1101.53
2025-1201.57
2026-0101.4
2026-0201.18
2026-0301.9
2026-0401.8
2026-0501.67
2026-0601.75
This device (reports/month)Average device in MQP, PLT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K090176 — cited as predicate by K142205

K142205 — cites (transitively): K003836 (d1), K012254 (d1), K030349 (d1), K032476 (d1), K061891 (d1), K090176 (d1) — cited as predicate by K151167, K151538, K151651, K161649, K190349, K191423, K193506

K151651 — cites (transitively): K081611 (d1), K142205 (d1), K003836 (d2), K012254 (d2), K030349 (d2), K032476 (d2), K061891 (d2), K090176 (d2) — cited as predicate by K152568, K162315, K172032, K180550, K180665, K181328, K183071, K193506, K212126

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