510(k) K033756 ยท HRS Plate, Fixation, Bone
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Feb 6, 2004 |
| Received | Dec 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21 Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.