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Anyplus II Spinal Fixation System
Model GS120-2300 · GS Medical Co., Ltd. · DI 08800104097959
HXX — Screwdriver · Class I · 21 CFR 888.4540
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080
UDILibrary device dossier · generated 2026-09-11 · 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
2.02
2019-02
0
2.38
2019-03
0
1.85
2019-04
0
2.04
2019-05
0
2.21
2019-06
0
1.91
2019-07
0
2.27
2019-08
0
1.95
2019-09
0
2.19
2019-10
0
3.01
2019-11
0
2.25
2019-12
0
2.47
2020-01
0
2.33
2020-02
0
2
2020-03
0
2.16
2020-04
0
1.92
2020-05
0
2.01
2020-06
0
2.41
2020-07
0
2.78
2020-08
0
2.67
2020-09
0
2.87
2020-10
0
3.15
2020-11
0
3.53
2020-12
0
3.1
2021-01
0
3.76
2021-02
0
3.12
2021-03
0
3.04
2021-04
0
2.84
2021-05
0
2.9
2021-06
0
2.83
2021-07
0
2.92
2021-08
0
2.46
2021-09
0
2.71
2021-10
0
2.55
2021-11
0
2.73
2021-12
0
3.24
2022-01
0
3.49
2022-02
0
3.11
2022-03
0
2.47
2022-04
0
2.72
2022-05
0
2.52
2022-06
0
2.53
2022-07
0
2.94
2022-08
0
2.8
2022-09
0
3.57
2022-10
0
2.67
2022-11
0
3.07
2022-12
0
2.63
2023-01
0
3.19
2023-02
0
2.79
2023-03
0
3.16
2023-04
0
2.61
2023-05
0
3.62
2023-06
0
3.03
2023-07
0
3.11
2023-08
0
2.47
2023-09
0
2.33
2023-10
0
2.38
2023-11
0
5.06
2023-12
0
2.97
2024-01
0
2.25
2024-02
0
2.57
2024-03
0
2.31
2024-04
0
2.03
2024-05
0
2.88
2024-06
0
2.59
2024-07
0
2.78
2024-08
0
2.26
2024-09
0
3.05
2024-10
0
2.42
2024-11
0
2.23
2024-12
0
1.85
2025-01
0
4.03
2025-02
0
3.22
2025-03
0
2.15
2025-04
0
2.24
2025-05
0
2.69
2025-06
0
2.48
2025-07
0
2.6
2025-08
0
2.59
2025-09
0
2.07
2025-10
0
2.01
2025-11
0
2.58
2025-12
0
2.85
2026-01
0
2.66
2026-02
0
2.08
2026-03
0
2.74
2026-04
0
2.33
2026-05
0
2.45
2026-06
0
2.62
This device (reports/month)Average device in HXX, 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.