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Gibralt
Model 05-004-09-2230 · Choice Spine, LP · DI 00840996169974
KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050
NKG — Posterior Cervical Screw System · Class II · 21 CFR 888.3075
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
2.08
2019-02
0
1.9
2019-03
0
1.9
2019-04
0
2.09
2019-05
0
2.08
2019-06
0
2.2
2019-07
0
1.63
2019-08
0
2.42
2019-09
0
1.86
2019-10
0
1.77
2019-11
0
2.07
2019-12
0
1.55
2020-01
0
2.69
2020-02
0
2.46
2020-03
0
2.51
2020-04
0
1.44
2020-05
0
2.08
2020-06
0
2.19
2020-07
0
1.69
2020-08
0
1.76
2020-09
0
2.04
2020-10
0
2.3
2020-11
0
2.14
2020-12
0
2.07
2021-01
0
2.05
2021-02
0
1.92
2021-03
0
2.19
2021-04
0
2.02
2021-05
0
1.95
2021-06
0
1.94
2021-07
0
8.17
2021-08
0
2
2021-09
0
1.72
2021-10
0
2.29
2021-11
0
1.86
2021-12
0
1.97
2022-01
0
2.03
2022-02
0
1.87
2022-03
0
1.72
2022-04
0
1.76
2022-05
0
1.66
2022-06
0
2.06
2022-07
0
2.98
2022-08
0
2.07
2022-09
0
2.84
2022-10
0
1.49
2022-11
0
1.83
2022-12
0
1.98
2023-01
0
1.78
2023-02
0
1.96
2023-03
0
2
2023-04
0
2.04
2023-05
0
2.02
2023-06
0
1.61
2023-07
0
1.77
2023-08
0
1.47
2023-09
0
2.61
2023-10
0
2.37
2023-11
0
2.09
2023-12
0
1.55
2024-01
0
2.38
2024-02
0
2.08
2024-03
0
3.58
2024-04
0
1.69
2024-05
0
3.28
2024-06
0
2.21
2024-07
0
1.9
2024-08
0
1.83
2024-09
0
2.44
2024-10
0
2.36
2024-11
0
1.85
2024-12
0
1.78
2025-01
0
2.41
2025-02
0
2.37
2025-03
0
2.08
2025-04
0
2.13
2025-05
0
2.42
2025-06
0
2.59
2025-07
0
1.83
2025-08
0
1.92
2025-09
0
1.89
2025-10
0
1.98
2025-11
0
1.99
2025-12
0
2.3
2026-01
0
2.53
2026-02
0
2.41
2026-03
0
2.43
2026-04
0
1.8
2026-05
0
2.34
2026-06
0
4.01
This device (reports/month)Average device in KWP, NKG (reports/device/month)
Regulatory clearances
K160697 SESE 2016-06-28 (k number procode)
Predicate lineage
K160697 — cites (transitively): K050979 (d1), K083071 (d1), K142838 (d1), K062254 (d2) — cited as predicate by K162266, K172139, K192354
Lineage extracted from public 510(k) summary text (heuristic).