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QUASAR Standalone ACIF System
Model GS136-0200 · GS Medical Co., Ltd. · DI 08809885799809
HTW — Bit, Drill · Class I · 21 CFR 888.4540
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080
UDILibrary device dossier · generated 2026-09-15 · 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
2.67
2019-02
0
2.73
2019-03
0
2.05
2019-04
0
1.89
2019-05
0
2.19
2019-06
0
2.14
2019-07
0
1.96
2019-08
0
2.09
2019-09
0
2.18
2019-10
0
2.85
2019-11
0
3.25
2019-12
0
2.83
2020-01
0
3.36
2020-02
0
3.06
2020-03
0
2.68
2020-04
0
2.64
2020-05
0
2.33
2020-06
0
2.97
2020-07
0
3.59
2020-08
0
4
2020-09
0
3.54
2020-10
0
3.47
2020-11
0
3.47
2020-12
0
3.77
2021-01
0
3.65
2021-02
0
2.87
2021-03
0
3.16
2021-04
0
2.96
2021-05
0
3.51
2021-06
0
3.94
2021-07
0
3.18
2021-08
0
3.43
2021-09
0
3.7
2021-10
0
3.29
2021-11
0
3.4
2021-12
0
3.47
2022-01
0
4.12
2022-02
0
4.03
2022-03
0
3.02
2022-04
0
3.54
2022-05
0
2.9
2022-06
0
3.41
2022-07
0
2.55
2022-08
0
3.43
2022-09
0
3.25
2022-10
0
3.42
2022-11
0
3.36
2022-12
0
4.11
2023-01
0
3.77
2023-02
0
3.33
2023-03
0
4.56
2023-04
0
4.32
2023-05
0
4.16
2023-06
0
3.85
2023-07
0
3.57
2023-08
0
2.6
2023-09
0
2.43
2023-10
0
2.94
2023-11
0
5.69
2023-12
0
3.19
2024-01
0
2.1
2024-02
0
2.77
2024-03
0
2.25
2024-04
0
3.21
2024-05
0
2.7
2024-06
0
2.47
2024-07
0
2.32
2024-08
0
2.76
2024-09
0
2.26
2024-10
0
2.8
2024-11
0
2.73
2024-12
0
2.11
2025-01
0
2.76
2025-02
0
2.04
2025-03
0
2.26
2025-04
0
2.31
2025-05
0
3.22
2025-06
0
2.82
2025-07
0
2.78
2025-08
0
2.92
2025-09
0
2.16
2025-10
0
2.5
2025-11
0
3.09
2025-12
0
2.9
2026-01
0
2.79
2026-02
0
1.99
2026-03
0
3.31
2026-04
0
2.98
2026-05
0
2.9
2026-06
0
2.84
This device (reports/month)Average device in HTW, 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.