Print-ready dossier — use your browser's print dialog to save as PDF.
Leforte System Bone Plate
Model 12-CD-012 · Jeil Medical Corporation · DI 08809265150305
JEY — Plate, Bone · Class II · 21 CFR 872.4760
KTW — Appliance, Fixation, Nail/Blade/Plate Combination, Single Component · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-13 · 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
1.41
2019-02
0
1.33
2019-03
0
2.4
2019-04
0
2.87
2019-05
0
3.18
2019-06
0
1.39
2019-07
0
1.76
2019-08
0
2
2019-09
0
2.17
2019-10
0
2.53
2019-11
0
1.72
2019-12
0
2.23
2020-01
0
2.54
2020-02
0
1.81
2020-03
0
2
2020-04
0
2.12
2020-05
0
2.31
2020-06
0
2
2020-07
0
2.11
2020-08
0
2.21
2020-09
0
2
2020-10
0
2.16
2020-11
0
1.63
2020-12
0
1.94
2021-01
0
2
2021-02
0
1.25
2021-03
0
2
2021-04
0
3.05
2021-05
0
3.43
2021-06
0
2.07
2021-07
0
1.33
2021-08
0
2.82
2021-09
0
1.55
2021-10
0
2.06
2021-11
0
1.69
2021-12
0
3.59
2022-01
0
1.9
2022-02
0
2.67
2022-03
0
3.5
2022-04
0
2.33
2022-05
0
1.76
2022-06
0
2.5
2022-07
0
2.16
2022-08
0
2.15
2022-09
0
1.6
2022-10
0
6.88
2022-11
0
2.13
2022-12
0
3.37
2023-01
0
2.42
2023-02
0
3.2
2023-03
0
2.63
2023-04
0
1.55
2023-05
0
2.7
2023-06
0
4.15
2023-07
0
3.81
2023-08
0
2.82
2023-09
0
2.36
2023-10
0
1.44
2023-11
0
2.54
2023-12
0
2.05
2024-01
0
2.64
2024-02
0
2.25
2024-03
0
2.23
2024-04
0
2.43
2024-05
0
2.29
2024-06
0
1.63
2024-07
0
1.55
2024-08
0
1.6
2024-09
0
1.81
2024-10
0
2.29
2024-11
0
2
2024-12
0
1.37
2025-01
0
1.5
2025-02
0
1.38
2025-03
0
2.24
2025-04
0
1.9
2025-05
0
2
2025-06
0
1.92
2025-07
0
3.13
2025-08
0
2.57
2025-09
0
1.55
2025-10
0
1.9
2025-11
0
1.56
2025-12
0
4.38
2026-01
0
1.57
2026-02
0
2.45
2026-03
0
1.11
2026-04
0
3.09
2026-05
0
2.09
2026-06
0
3.56
This device (reports/month)Average device in JEY, KTW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K023360 — cited as predicate by K131311, K132876
K091679 — cited as predicate by K112457, K112812, K140037, K182758
K103778 — cited as predicate by K112812, K182758
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Jeil Medical Corporation
OAI 2014-01-23 Jeil Medical Corporation · 14 citations
OAI 2014-01-23 Jeil Medical Corporation · 14 citations