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SI-LOK
Model 139.524S · GLOBUS MEDICAL, INC. · DI 00889095184921
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
OUR — Sacroiliac Joint Fixation · Class II · 21 CFR 888.3040
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.15
2019-02
0
1.63
2019-03
0
1.68
2019-04
0
2.22
2019-05
0
1.77
2019-06
0
1.82
2019-07
0
2.06
2019-08
0
2.04
2019-09
0
1.76
2019-10
0
1.74
2019-11
0
1.96
2019-12
0
2.49
2020-01
0
2.54
2020-02
0
2.18
2020-03
0
1.89
2020-04
0
1.86
2020-05
0
1.79
2020-06
0
2.07
2020-07
0
2.68
2020-08
0
2.48
2020-09
0
2.45
2020-10
0
2.23
2020-11
0
2.79
2020-12
0
2.46
2021-01
0
1.85
2021-02
0
2.3
2021-03
0
2.59
2021-04
0
2.63
2021-05
0
2.4
2021-06
0
2.18
2021-07
0
2.28
2021-08
0
2.13
2021-09
0
2.34
2021-10
0
2.02
2021-11
0
2.25
2021-12
0
2.33
2022-01
0
2.88
2022-02
0
2.2
2022-03
0
2.02
2022-04
0
1.94
2022-05
0
2.38
2022-06
0
2.22
2022-07
0
2.17
2022-08
0
2.48
2022-09
0
2.88
2022-10
0
3
2022-11
0
2.99
2022-12
0
5.47
2023-01
0
2.72
2023-02
0
2.85
2023-03
0
3.08
2023-04
0
2.76
2023-05
0
3.3
2023-06
0
2.94
2023-07
0
2.27
2023-08
0
2.15
2023-09
0
2.02
2023-10
0
2.14
2023-11
0
1.87
2023-12
0
2.44
2024-01
0
2.76
2024-02
0
1.8
2024-03
0
2.33
2024-04
0
2.12
2024-05
0
2.28
2024-06
0
2.26
2024-07
0
2.46
2024-08
0
2.12
2024-09
0
2.15
2024-10
0
2.19
2024-11
0
2.05
2024-12
0
2.75
2025-01
0
2.2
2025-02
0
2.25
2025-03
0
2.06
2025-04
0
2.54
2025-05
0
2.49
2025-06
0
2.01
2025-07
0
2.13
2025-08
0
2.39
2025-09
0
2.06
2025-10
0
2.55
2025-11
0
2.04
2025-12
0
2.73
2026-01
0
2.06
2026-02
0
2.35
2026-03
0
2.61
2026-04
0
2.17
2026-05
0
2.56
2026-06
0
2.32
This device (reports/month)Average device in HWC, OUR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K112028 — cited as predicate by K140079, K141106, K141246, K141549, K151462, K152681, K171595, K171651, K173201, K181881, K183119, K190580, K230446
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