510(k) K182425 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Universal Mesh - Sterile
| Applicant | Stryker Leibinger GmbH & Co KG, Freiburg, DE |
| Decision | Substantially Equivalent, Nov 6, 2018 |
| Received | Sep 6, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182425
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 8, 2024 | Stryker Leibinger GmbH & Co. KG Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton.
Catalog Number: 56-90614 Open, Classified |
GWO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.