510(k) K260958 · HRS Plate, Fixation, Bone
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate wit
| Applicant | I.T.S. GmbH, Laßnitzhöhe, AT |
| Decision | Substantially Equivalent, Jun 16, 2026 |
| Received | Mar 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260958
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.