510(k) K260054 · HRS Plate, Fixation, Bone
I.T.S. PRS Phoenix II
| Applicant | I.T.S. GmbH, Laßnitzhöhe, AT |
| Decision | Substantially Equivalent, Apr 24, 2026 |
| Received | Jan 8, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260054
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.