510(k) K063166 ยท HRS Plate, Fixation, Bone
I.T.S. PELVIC RECONSTRUCTION SYSTEM
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Dec 22, 2006 |
| Received | Oct 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers.
1. Fixation Screw; Article Number: 70312.
2. Spike short; Article Number: 70314. Open, Classified |
HRS | None listed |
| May 9, 2019 | I.T.S. GmbH Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.