510(k) K051412 ยท HRS Plate, Fixation, Bone
HUMERAL HEAD PLATE WITH ANGULAR STABILITY
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Jul 11, 2005 |
| Received | May 31, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051412
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136 Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.