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COLONIAL
Model 365.710 · GLOBUS MEDICAL, INC. · DI 00849044029505
ODP — Intervertebral Fusion Device With Bone Graft, Cervical · Class II · 21 CFR 888.3080
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
1
2019-03
0
1
2019-04
0
1
2019-05
0
1.5
2019-06
0
1.17
2019-07
0
2
2019-08
0
6.67
2019-09
0
1
2019-10
0
3.56
2019-11
0
1.33
2019-12
0
1
2020-01
0
1.33
2020-02
0
2
2020-03
0
1.5
2020-04
0
1.5
2020-05
0
1.57
2020-06
0
1
2020-07
0
1.33
2020-08
0
1.42
2020-09
0
1
2020-10
0
1.58
2020-11
0
1
2020-12
0
2
2021-01
0
1.25
2021-02
0
1.5
2021-03
0
1.71
2021-04
0
1
2021-05
0
1
2021-06
0
4.05
2021-07
0
1.25
2021-08
0
1
2021-09
0
1.86
2021-10
0
1
2021-11
0
1
2021-12
0
1.38
2022-01
0
1.25
2022-02
0
1.5
2022-03
0
1.64
2022-04
0
1.2
2022-05
0
1.85
2022-06
0
1.4
2022-07
0
1.29
2022-08
0
1.43
2022-09
0
2.11
2022-10
0
1.33
2022-11
0
2
2022-12
0
1
2023-02
0
1
2023-03
0
1.57
2023-04
0
1
2023-05
0
1.5
2023-06
0
1
2023-07
0
1
2023-08
0
5.78
2023-09
0
1
2023-10
0
1.6
2023-11
0
1
2023-12
0
1.25
2024-01
0
4
2024-02
0
1.5
2024-03
0
1.5
2024-04
0
1.5
2024-05
0
1.33
2024-06
0
1.5
2024-07
0
1.67
2024-08
0
2
2024-09
0
1.67
2024-10
0
1.2
2024-11
0
1.6
2024-12
0
1.71
2025-01
0
1.43
2025-02
0
1.78
2025-03
0
1.4
2025-04
0
1.88
2025-05
0
1.25
2025-06
0
1.6
2025-07
0
2.4
2025-08
0
1.67
2025-09
0
1.33
2025-10
0
1.5
2025-11
0
1.83
2025-12
0
1.67
2026-01
0
1.38
2026-02
0
1.38
2026-03
0
1.63
2026-04
0
1.38
2026-05
0
1.71
2026-06
0
1.89
This device (reports/month)Average device in ODP (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K072991 — cited as predicate by K130478, K143578, K160125, K171848, K173722, K192044
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