510(k) K063672 ยท HRS Plate, Fixation, Bone
FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Feb 2, 2007 |
| Received | Dec 11, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063672
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers.
1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602- Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.