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Unnamed device
Model 393.731 · Synthes GmbH · DI 10886982199300
KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030
LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-16 · 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
1.48
2019-02
0
1.53
2019-03
0
1.32
2019-04
0
1.96
2019-05
0
1.38
2019-06
0
1.76
2019-07
0
2.04
2019-08
0
1.8
2019-09
0
1.42
2019-10
0
1.25
2019-11
0
1.32
2019-12
0
1.33
2020-01
0
1.57
2020-02
0
2.31
2020-03
0
1.43
2020-04
0
1.5
2020-05
0
1
2020-06
0
1.96
2020-07
0
1.59
2020-08
0
1.97
2020-09
0
2.18
2020-10
0
2.4
2020-11
0
1.72
2020-12
0
2.23
2021-01
0
1.53
2021-02
0
2.68
2021-03
0
2.65
2021-04
0
2.43
2021-05
0
2.72
2021-06
0
1.9
2021-07
0
1.63
2021-08
0
1.62
2021-09
0
1.76
2021-10
0
1.48
2021-11
0
2.78
2021-12
0
1.61
2022-01
0
2
2022-02
0
2.6
2022-03
0
2
2022-04
0
2.23
2022-05
0
4.67
2022-06
0
2.22
2022-07
0
2.26
2022-08
0
1.91
2022-09
0
2.42
2022-10
0
2.81
2022-11
0
3.33
2022-12
0
2.8
2023-01
0
2.67
2023-02
0
2.14
2023-03
0
2.09
2023-04
0
2.31
2023-05
0
3.08
2023-06
0
1.94
2023-07
0
2.06
2023-08
0
1.42
2023-09
0
2.11
2023-10
0
1.18
2023-11
0
1.23
2023-12
0
1.31
2024-01
0
1.2
2024-02
0
2
2024-03
0
1.35
2024-04
0
1.6
2024-05
0
1.44
2024-06
0
1.67
2024-07
0
1.27
2024-08
0
1.56
2024-09
0
1.28
2024-10
0
2.27
2024-11
0
1.63
2024-12
0
3.6
2025-01
0
1.29
2025-02
0
1.57
2025-03
0
1.25
2025-04
0
2
2025-05
0
1.44
2025-06
0
1.23
2025-07
0
1.73
2025-08
0
1.2
2025-09
0
1.47
2025-10
0
2.48
2025-11
0
1.7
2025-12
0
1.68
2026-01
0
1.53
2026-02
0
1.2
2026-03
0
1.21
2026-04
0
1.67
2026-05
0
2.91
2026-06
0
1.36
This device (reports/month)Average device in KTT, LXT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K950384 — cited as predicate by K122455
Lineage extracted from public 510(k) summary text (heuristic).