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Unnamed device
Model 458.80S · SYNTHES (U.S.A.) LP · DI 10886982230065
JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-12 · 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
1.43
2019-02
0
1.65
2019-03
0
1.25
2019-04
0
1.14
2019-05
0
2.3
2019-06
0
1.88
2019-07
0
2.4
2019-08
0
2
2019-09
0
1.27
2019-10
0
2.07
2019-11
0
2.36
2019-12
0
2.08
2020-01
0
1.4
2020-02
0
2.17
2020-03
0
1.67
2020-04
0
1.86
2020-05
0
1.25
2020-06
0
2.25
2020-07
0
1.85
2020-08
0
1.88
2020-09
0
2.78
2020-10
0
1.9
2020-11
0
2
2020-12
0
1.65
2021-01
0
1.71
2021-02
0
1.83
2021-03
0
1.89
2021-04
0
2
2021-05
0
2.13
2021-06
0
1.87
2021-07
0
1.79
2021-08
0
3.06
2021-09
0
1.96
2021-10
0
2
2021-11
0
1.78
2021-12
0
2.18
2022-01
0
2.07
2022-02
0
2.5
2022-03
0
1.9
2022-04
0
1.68
2022-05
0
1.7
2022-06
0
2.42
2022-07
0
2.22
2022-08
0
2.4
2022-09
0
3.96
2022-10
0
3.06
2022-11
0
3.82
2022-12
0
3.08
2023-01
0
3.14
2023-02
0
3.93
2023-03
0
4.56
2023-04
0
3.09
2023-05
0
4.53
2023-06
0
4.15
2023-07
0
3.1
2023-08
0
2.11
2023-09
0
1.82
2023-10
0
1.81
2023-11
0
1.33
2023-12
0
1.85
2024-01
0
2.88
2024-02
0
1.81
2024-03
0
2.18
2024-04
0
1.83
2024-05
0
1.67
2024-06
0
2.25
2024-07
0
1.5
2024-08
0
1.88
2024-09
0
2.21
2024-10
0
2.38
2024-11
0
3.08
2024-12
0
2.59
2025-01
0
3.33
2025-02
0
2.75
2025-03
0
2.54
2025-04
0
6.64
2025-05
0
2.89
2025-06
0
2.2
2025-07
0
3.18
2025-08
0
2.61
2025-09
0
3.09
2025-10
0
3.22
2025-11
0
3.29
2025-12
0
3.93
2026-01
0
2.75
2026-02
0
3.13
2026-03
0
2.2
2026-04
0
2.07
2026-05
0
2.58
2026-06
0
2.43
This device (reports/month)Average device in JDS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K914453 — cited as predicate by K111056, K133166, K182783, K233150
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SYNTHES (U.S.A.) LP