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COALITION

Model 184.054 · GLOBUS MEDICAL, INC. · DI 00849044007527

ODP — Intervertebral Fusion Device With Bone Graft, Cervical · 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.

23572019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 1.17/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 6.67/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3.56/device2019-11: 0 reports for this device; peer average 1.33/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.33/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.5/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 1.57/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.33/device2020-08: 0 reports for this device; peer average 1.42/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.58/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1.25/device2021-02: 0 reports for this device; peer average 1.5/device2021-03: 0 reports for this device; peer average 1.71/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 4.05/device2021-07: 0 reports for this device; peer average 1.25/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.86/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.38/device2022-01: 0 reports for this device; peer average 1.25/device2022-02: 0 reports for this device; peer average 1.5/device2022-03: 0 reports for this device; peer average 1.64/device2022-04: 0 reports for this device; peer average 1.2/device2022-05: 0 reports for this device; peer average 1.85/device2022-06: 0 reports for this device; peer average 1.4/device2022-07: 0 reports for this device; peer average 1.29/device2022-08: 0 reports for this device; peer average 1.43/device2022-09: 0 reports for this device; peer average 2.11/device2022-10: 0 reports for this device; peer average 1.33/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.57/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 5.78/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.6/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 4/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 1.33/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 1.2/device2024-11: 0 reports for this device; peer average 1.6/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 1.43/device2025-02: 0 reports for this device; peer average 1.78/device2025-03: 0 reports for this device; peer average 1.4/device2025-04: 0 reports for this device; peer average 1.88/device2025-05: 0 reports for this device; peer average 1.25/device2025-06: 0 reports for this device; peer average 1.6/device2025-07: 0 reports for this device; peer average 2.4/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1.33/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1.83/device2025-12: 0 reports for this device; peer average 1.67/device2026-01: 0 reports for this device; peer average 1.38/device2026-02: 0 reports for this device; peer average 1.38/device2026-03: 0 reports for this device; peer average 1.63/device2026-04: 0 reports for this device; peer average 1.38/device2026-05: 0 reports for this device; peer average 1.71/device2026-06: 0 reports for this device; peer average 1.89/device02030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0301
2019-0401
2019-0501.5
2019-0601.17
2019-0702
2019-0806.67
2019-0901
2019-1003.56
2019-1101.33
2019-1201
2020-0101.33
2020-0202
2020-0301.5
2020-0401.5
2020-0501.57
2020-0601
2020-0701.33
2020-0801.42
2020-0901
2020-1001.58
2020-1101
2020-1202
2021-0101.25
2021-0201.5
2021-0301.71
2021-0401
2021-0501
2021-0604.05
2021-0701.25
2021-0801
2021-0901.86
2021-1001
2021-1101
2021-1201.38
2022-0101.25
2022-0201.5
2022-0301.64
2022-0401.2
2022-0501.85
2022-0601.4
2022-0701.29
2022-0801.43
2022-0902.11
2022-1001.33
2022-1102
2022-1201
2023-0201
2023-0301.57
2023-0401
2023-0501.5
2023-0601
2023-0701
2023-0805.78
2023-0901
2023-1001.6
2023-1101
2023-1201.25
2024-0104
2024-0201.5
2024-0301.5
2024-0401.5
2024-0501.33
2024-0601.5
2024-0701.67
2024-0802
2024-0901.67
2024-1001.2
2024-1101.6
2024-1201.71
2025-0101.43
2025-0201.78
2025-0301.4
2025-0401.88
2025-0501.25
2025-0601.6
2025-0702.4
2025-0801.67
2025-0901.33
2025-1001.5
2025-1101.83
2025-1201.67
2026-0101.38
2026-0201.38
2026-0301.63
2026-0401.38
2026-0501.71
2026-0601.89
This device (reports/month)Average device in ODP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K083389 — cited as predicate by K112068, K112388, K113796, K120840, K121569, K122771, K130478, K131449, K132029, K132999, K143578, K151939, K191477, K210382

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

Manufacturer compliance record — GLOBUS MEDICAL, INC.

  • Warning Letter 2024-07-15 Globus Medical, Inc.
  • Warning Letter 2024-07-15 Globus Medical, Inc.
  • Warning Letter 2013-09-26 Globus Medical, Inc.
  • Warning Letter 2013-09-26 Globus Medical, Inc.
  • VAI 2025-10-16 Globus Medical, Inc. · 1 citations
  • VAI 2025-10-16 Globus Medical, Inc. · 1 citations
  • OAI 2025-08-13 Nevro Corporation · 6 citations
  • NAI 2025-03-25 Nuvasive Manufacturing LLC. · 0 citations
  • OAI 2024-03-07 Globus Medical, Inc. · 6 citations
  • OAI 2024-03-07 Globus Medical, Inc. · 6 citations
  • VAI 2023-12-20 Nevro Corporation · 1 citations
  • NAI 2022-07-29 Nevro Medical SRL · 0 citations
  • NAI 2022-04-26 Nevro Corporation · 0 citations
  • NAI 2019-10-23 Globus Medical, Inc. · 0 citations
  • NAI 2019-10-23 Globus Medical, Inc. · 0 citations
  • VAI 2019-09-27 Globus Medical, Inc. · 7 citations
  • VAI 2019-09-27 Globus Medical, Inc. · 7 citations
  • NAI 2019-03-21 Nevro Corporation · 0 citations
  • VAI 2019-02-13 Globus Medical, Inc. · 2 citations
  • VAI 2019-02-13 Globus Medical, Inc. · 2 citations
  • NAI 2018-03-16 Nevro Corporation · 0 citations
  • VAI 2017-11-03 Nevro Corporation · 5 citations
  • NAI 2017-09-25 Globus Medical, Inc. · 0 citations
  • NAI 2017-09-25 Globus Medical, Inc. · 0 citations