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Unnamed device
Model 458.68 · SYNTHES (U.S.A.) LP · DI 10886982229939
HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020
JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030
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
1.42
2019-02
0
1.49
2019-03
0
1.52
2019-04
0
1.34
2019-05
0
1.45
2019-06
0
1.59
2019-07
0
1.64
2019-08
0
1.73
2019-09
0
1.36
2019-10
0
1.56
2019-11
0
1.79
2019-12
0
1.59
2020-01
0
1.51
2020-02
0
1.48
2020-03
0
1.48
2020-04
0
1.95
2020-05
0
1.76
2020-06
0
2.17
2020-07
0
2.23
2020-08
0
2.86
2020-09
0
2.17
2020-10
0
2.44
2020-11
0
3.12
2020-12
0
3.17
2021-01
0
2.82
2021-02
0
2.91
2021-03
0
3.15
2021-04
0
3.37
2021-05
0
3.93
2021-06
0
2.98
2021-07
0
2.36
2021-08
0
2.31
2021-09
0
2.18
2021-10
0
1.79
2021-11
0
3.17
2021-12
0
2.32
2022-01
0
2.8
2022-02
0
2.13
2022-03
0
2.2
2022-04
0
2.2
2022-05
0
2.01
2022-06
0
2.24
2022-07
0
1.86
2022-08
0
1.98
2022-09
0
2.69
2022-10
0
2.49
2022-11
0
2.64
2022-12
0
2.34
2023-01
0
2.41
2023-02
0
2.46
2023-03
0
2.97
2023-04
0
2.47
2023-05
0
2.93
2023-06
0
2.8
2023-07
0
2.05
2023-08
0
1.76
2023-09
0
1.5
2023-10
0
1.5
2023-11
0
1.48
2023-12
0
1.57
2024-01
0
1.81
2024-02
0
1.53
2024-03
0
1.76
2024-04
0
1.45
2024-05
0
1.7
2024-06
0
1.76
2024-07
0
1.44
2024-08
0
1.92
2024-09
0
2.2
2024-10
0
1.76
2024-11
0
1.81
2024-12
0
1.87
2025-01
0
1.93
2025-02
0
1.75
2025-03
0
1.7
2025-04
0
2.22
2025-05
0
1.76
2025-06
0
1.51
2025-07
0
1.75
2025-08
0
1.73
2025-09
0
1.63
2025-10
0
1.74
2025-11
0
1.97
2025-12
0
2.05
2026-01
0
1.99
2026-02
0
1.75
2026-03
0
1.82
2026-04
0
1.67
2026-05
0
1.79
2026-06
0
1.72
This device (reports/month)Average device in HSB, JDS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K914453 — cited as predicate by K111056, K133166, K182783, K233150
K933518 — cited as predicate by K160553, K182783
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SYNTHES (U.S.A.) LP