510(k) K210935 · HRS Plate, Fixation, Bone
I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
| Applicant | I.T.S. GmbH, Laßnitzhöhe, AT |
| Decision | Substantially Equivalent, Aug 31, 2022 |
| Received | Mar 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210935
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers.
1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16.
Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.