Leforte Neuro System Bone Plate
Model N16-GP-010S · Jeil Medical Corporation · DI 08809265151913
GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320
GXR — Cover, Burr Hole · Class II · 21 CFR 882.5250
HBW — Fastener, Plate, Cranioplasty · Class II · 21 CFR 882.5360
JEY — Plate, Bone · Class II · 21 CFR 872.4760
UDILibrary device dossier · generated 2026-09-15 · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.45 |
| 2019-02 | 0 | 1.29 |
| 2019-03 | 0 | 2.52 |
| 2019-04 | 0 | 2.48 |
| 2019-05 | 0 | 3.1 |
| 2019-06 | 0 | 1.41 |
| 2019-07 | 0 | 1.73 |
| 2019-08 | 0 | 2.07 |
| 2019-09 | 0 | 1.88 |
| 2019-10 | 0 | 2.5 |
| 2019-11 | 0 | 1.8 |
| 2019-12 | 0 | 3.54 |
| 2020-01 | 0 | 2.47 |
| 2020-02 | 0 | 1.77 |
| 2020-03 | 0 | 2.43 |
| 2020-04 | 0 | 2 |
| 2020-05 | 0 | 2.39 |
| 2020-06 | 0 | 2.41 |
| 2020-07 | 0 | 2.5 |
| 2020-08 | 0 | 2.1 |
| 2020-09 | 0 | 2.66 |
| 2020-10 | 0 | 2.16 |
| 2020-11 | 0 | 1.89 |
| 2020-12 | 0 | 2.24 |
| 2021-01 | 0 | 2 |
| 2021-02 | 0 | 1.42 |
| 2021-03 | 0 | 2.28 |
| 2021-04 | 0 | 3.92 |
| 2021-05 | 0 | 2.95 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 1.24 |
| 2021-08 | 0 | 2.9 |
| 2021-09 | 0 | 1.68 |
| 2021-10 | 0 | 2.26 |
| 2021-11 | 0 | 1.77 |
| 2021-12 | 0 | 2.74 |
| 2022-01 | 0 | 2.32 |
| 2022-02 | 0 | 3.69 |
| 2022-03 | 0 | 3.84 |
| 2022-04 | 0 | 1.74 |
| 2022-05 | 0 | 1.64 |
| 2022-06 | 0 | 3.46 |
| 2022-07 | 0 | 2.04 |
| 2022-08 | 0 | 2.03 |
| 2022-09 | 0 | 1.47 |
| 2022-10 | 0 | 5.85 |
| 2022-11 | 0 | 2.33 |
| 2022-12 | 0 | 3.66 |
| 2023-01 | 0 | 2.5 |
| 2023-02 | 0 | 3.04 |
| 2023-03 | 0 | 3.46 |
| 2023-04 | 0 | 5.06 |
| 2023-05 | 0 | 2.21 |
| 2023-06 | 0 | 6.03 |
| 2023-07 | 0 | 2.76 |
| 2023-08 | 0 | 2.57 |
| 2023-09 | 0 | 2.43 |
| 2023-10 | 0 | 2.11 |
| 2023-11 | 0 | 2.64 |
| 2023-12 | 0 | 1.79 |
| 2024-01 | 0 | 3.53 |
| 2024-02 | 0 | 2.68 |
| 2024-03 | 0 | 2.32 |
| 2024-04 | 0 | 2.81 |
| 2024-05 | 0 | 2.1 |
| 2024-06 | 0 | 1.77 |
| 2024-07 | 0 | 1.35 |
| 2024-08 | 0 | 1.42 |
| 2024-09 | 0 | 2.5 |
| 2024-10 | 0 | 3.23 |
| 2024-11 | 0 | 3.13 |
| 2024-12 | 0 | 1.59 |
| 2025-01 | 0 | 1.64 |
| 2025-02 | 0 | 1.27 |
| 2025-03 | 0 | 1.93 |
| 2025-04 | 0 | 1.88 |
| 2025-05 | 0 | 2.48 |
| 2025-06 | 0 | 2.11 |
| 2025-07 | 0 | 4.1 |
| 2025-08 | 0 | 2.33 |
| 2025-09 | 0 | 1.55 |
| 2025-10 | 0 | 1.73 |
| 2025-11 | 0 | 1.35 |
| 2025-12 | 0 | 4.25 |
| 2026-01 | 0 | 1.72 |
| 2026-02 | 0 | 2.25 |
| 2026-03 | 0 | 1.43 |
| 2026-04 | 0 | 4.43 |
| 2026-05 | 0 | 2.37 |
| 2026-06 | 0 | 3.87 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K091679 — cited as predicate by K112457, K112812, K140037, K182758
K103778 — cited as predicate by K112812, K182758
K112812 — cites (transitively): K091679 (d1), K103778 (d1) — cited as predicate by K141644, K141911, K170313, K170368, K170705, K170780, K171285
K141452 — cited as predicate by K170368, K210099, K212391, K250297, K252251, K252958
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