510(k) K060156 ยท HRS Plate, Fixation, Bone
STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Mar 20, 2006 |
| Received | Jan 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers.
1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9.
2. Forearm Plate, Straight; Open, Classified |
HRS | None listed |
| Mar 20, 2026 | I.T.S. GmbH I.T.S. Screw System with the below descriptions and corresponding article numbers.
1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404 Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.