Print-ready dossier — use your browser's print dialog to save as PDF.
Unnamed device
Model 02.111.300 · Synthes GmbH · DI 10886982031587
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
HWC — Screw, Fixation, Bone · 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
2.04
2019-02
0
1.58
2019-03
0
1.74
2019-04
0
2.29
2019-05
0
1.72
2019-06
0
1.74
2019-07
0
1.9
2019-08
0
1.85
2019-09
0
1.72
2019-10
0
1.62
2019-11
0
1.89
2019-12
0
2.26
2020-01
0
2.4
2020-02
0
1.44
2020-03
0
1.78
2020-04
0
1.9
2020-05
0
1.76
2020-06
0
2.01
2020-07
0
2.34
2020-08
0
2.42
2020-09
0
2.58
2020-10
0
2.09
2020-11
0
2.65
2020-12
0
2.39
2021-01
0
1.82
2021-02
0
2.14
2021-03
0
2.38
2021-04
0
2.76
2021-05
0
2.5
2021-06
0
2.14
2021-07
0
2.29
2021-08
0
1.99
2021-09
0
2.21
2021-10
0
2.05
2021-11
0
2.19
2021-12
0
2.29
2022-01
0
2.92
2022-02
0
2.13
2022-03
0
1.89
2022-04
0
1.98
2022-05
0
2.2
2022-06
0
2.27
2022-07
0
2.21
2022-08
0
2.3
2022-09
0
2.7
2022-10
0
3
2022-11
0
2.97
2022-12
0
4.54
2023-01
0
2.64
2023-02
0
2.75
2023-03
0
3.05
2023-04
0
2.91
2023-05
0
3.6
2023-06
0
2.95
2023-07
0
2.26
2023-08
0
2.19
2023-09
0
2.04
2023-10
0
2.25
2023-11
0
1.92
2023-12
0
2.43
2024-01
0
2.52
2024-02
0
1.78
2024-03
0
2.15
2024-04
0
2.11
2024-05
0
2.17
2024-06
0
2.29
2024-07
0
2.38
2024-08
0
2.18
2024-09
0
1.95
2024-10
0
2.23
2024-11
0
1.91
2024-12
0
2.81
2025-01
0
2
2025-02
0
2.06
2025-03
0
2.32
2025-04
0
2.29
2025-05
0
2.35
2025-06
0
1.89
2025-07
0
2.12
2025-08
0
2.27
2025-09
0
1.96
2025-10
0
2.29
2025-11
0
1.99
2025-12
0
2.63
2026-01
0
1.93
2026-02
0
2.21
2026-03
0
2.79
2026-04
0
2.18
2026-05
0
2.41
2026-06
0
2.17
This device (reports/month)Average device in HRS, HWC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K103243 — cites (transitively): K021321 (d1), K990094 (d1), K991873 (d1) — cited as predicate by K123562, K160553, K221150
Lineage extracted from public 510(k) summary text (heuristic).