510(k) K050852 ยท HRS Plate, Fixation, Bone
CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Jun 22, 2005 |
| Received | Apr 4, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050852
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH Claviculaplate with Angular Stability, with the below descriptions and associated article numbers.
1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10.
2. Clavicle Pla Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.