Print-ready dossier — use your browser's print dialog to save as PDF.
AnyPlus® Cervical PEEK Cage System
Model GS138-5234 · GS Medical Co., Ltd. · DI 08800104077395
HTR — Rasp · Class I · 21 CFR 878.4800
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080
UDILibrary device dossier · generated 2026-09-13 · 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
1.52
2019-02
0
1.22
2019-03
0
1.73
2019-04
0
1.46
2019-05
0
1.6
2019-06
0
1.58
2019-07
0
1.62
2019-08
0
1.36
2019-09
0
1.32
2019-10
0
1.87
2019-11
0
1.58
2019-12
0
1.36
2020-01
0
1.67
2020-02
0
1.73
2020-03
0
1.58
2020-04
0
1.43
2020-05
0
1.64
2020-06
0
1.82
2020-07
0
1.85
2020-08
0
1.63
2020-09
0
2.52
2020-10
0
2.05
2020-11
0
2.1
2020-12
0
1.76
2021-01
0
1.67
2021-02
0
1.72
2021-03
0
2
2021-04
0
1.53
2021-05
0
1.6
2021-06
0
2.23
2021-07
0
1.73
2021-08
0
2.21
2021-09
0
1.68
2021-10
0
2.11
2021-11
0
1.84
2021-12
0
2.53
2022-01
0
3.07
2022-02
0
2.62
2022-03
0
1.77
2022-04
0
1.77
2022-05
0
2.1
2022-06
0
1.86
2022-07
0
2.21
2022-08
0
1.86
2022-09
0
1.78
2022-10
0
1.88
2022-11
0
1.93
2022-12
0
1.68
2023-01
0
2.42
2023-02
0
2.05
2023-03
0
1.71
2023-04
0
1.78
2023-05
0
2.04
2023-06
0
1.75
2023-07
0
2.04
2023-08
0
1.73
2023-09
0
1.85
2023-10
0
1.85
2023-11
0
9.77
2023-12
0
3.87
2024-01
0
1.86
2024-02
0
2.13
2024-03
0
1.88
2024-04
0
1.36
2024-05
0
1.58
2024-06
0
1.76
2024-07
0
1.97
2024-08
0
2.27
2024-09
0
1.9
2024-10
0
2.11
2024-11
0
1.74
2024-12
0
1.69
2025-01
0
1.84
2025-02
0
1.66
2025-03
0
1.66
2025-04
0
1.6
2025-05
0
1.65
2025-06
0
2.02
2025-07
0
1.88
2025-08
0
1.59
2025-09
0
1.59
2025-10
0
1.71
2025-11
0
2.03
2025-12
0
1.85
2026-01
0
1.94
2026-02
0
1.52
2026-03
0
2.75
2026-04
0
1.57
2026-05
0
1.62
2026-06
0
1.6
This device (reports/month)Average device in HTR, MAX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K100516 — cited as predicate by K110783, K121567, K221687, K221719, K221844, K223868
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — GS Medical Co., Ltd.