510(k) K052368 ยท HRS Plate, Fixation, Bone
OLECRANONPLATE WITH ANGULAR STABILITY
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Oct 17, 2005 |
| Received | Aug 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers.
1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9.
2. Olecranon Plate; Article Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.