510(k) K080184 ยท HRS Plate, Fixation, Bone
DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Mar 26, 2008 |
| Received | Jan 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080184
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers.
1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16- Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.