Unnamed device
Model 78-80010 · Stryker Leibinger GmbH & Co. KG · DI 07613327300048
GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320
UDILibrary device dossier · generated 2026-09-06 · 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 | 1.5 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2.71 |
| 2019-04 | 0 | 1.5 |
| 2019-05 | 0 | 2 |
| 2019-06 | 0 | 1.25 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1.5 |
| 2019-12 | 0 | 12 |
| 2020-01 | 0 | 2.14 |
| 2020-02 | 0 | 1.64 |
| 2020-03 | 0 | 2.75 |
| 2020-04 | 0 | 1.6 |
| 2020-05 | 0 | 2.57 |
| 2020-06 | 0 | 2.5 |
| 2020-07 | 0 | 3 |
| 2020-08 | 0 | 1.86 |
| 2020-09 | 0 | 4 |
| 2020-10 | 0 | 1.9 |
| 2020-11 | 0 | 2 |
| 2020-12 | 0 | 3 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 1.75 |
| 2021-04 | 0 | 5 |
| 2021-05 | 0 | 1.33 |
| 2021-06 | 0 | 1.75 |
| 2021-07 | 0 | 1.2 |
| 2021-08 | 0 | 2.5 |
| 2021-09 | 0 | 1.67 |
| 2021-10 | 0 | 2.71 |
| 2021-11 | 0 | 1.5 |
| 2021-12 | 0 | 1.38 |
| 2022-01 | 0 | 2.25 |
| 2022-02 | 0 | 4.4 |
| 2022-03 | 0 | 3.5 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 1.4 |
| 2022-06 | 0 | 6.4 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 1.6 |
| 2022-09 | 0 | 1.25 |
| 2022-10 | 0 | 2 |
| 2022-11 | 0 | 3.25 |
| 2022-12 | 0 | 4.1 |
| 2023-01 | 0 | 1.67 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 4 |
| 2023-04 | 0 | 14.2 |
| 2023-05 | 0 | 1.67 |
| 2023-06 | 0 | 6.5 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 1.25 |
| 2023-09 | 0 | 1.75 |
| 2023-10 | 0 | 3.5 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1.5 |
| 2024-01 | 0 | 5.5 |
| 2024-02 | 0 | 2.75 |
| 2024-03 | 0 | 1.75 |
| 2024-04 | 0 | 2.55 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1.75 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1.2 |
| 2024-09 | 0 | 6 |
| 2024-10 | 0 | 4.33 |
| 2024-11 | 0 | 3.5 |
| 2024-12 | 0 | 1.33 |
| 2025-01 | 0 | 1.83 |
| 2025-02 | 0 | 1 |
| 2025-03 | 0 | 1.33 |
| 2025-04 | 0 | 1.64 |
| 2025-05 | 0 | 2.5 |
| 2025-06 | 0 | 2 |
| 2025-07 | 0 | 3.5 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 1.17 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 2.8 |
| 2026-01 | 0 | 1.86 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 4.5 |
| 2026-04 | 0 | 10 |
| 2026-05 | 0 | 2.33 |
| 2026-06 | 0 | 3.4 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K152076 — cites (transitively): K121153 (d1), K053199 (d2) — cited as predicate by K191916
K153248 — cites (transitively): K121153 (d1), K053199 (d2) — cited as predicate by K190229
K190229 — cites (transitively): K153248 (d1), K121153 (d2), K053199 (d3) — cited as predicate by K201052, K203055
K203055 — cites (transitively): K190229 (d1), K153248 (d2), K121153 (d3), K053199 (d4) — cited as predicate by K203066, K254233
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Stryker Leibinger GmbH & Co. KG
- NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
- NAI 2017-07-27 Stryker Leibinger GmbH & Co. KG · 0 citations
- NAI 2013-11-14 Stryker Leibinger GmbH & Co. KG · 0 citations