510(k) K130008 ยท HRS Plate, Fixation, Bone
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
| Applicant | I.T.S. GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Jun 25, 2013 |
| Received | Jan 2, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers.
1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.