510(k) K131722 ยท HRS Plate, Fixation, Bone
I.T.S. EXTREMITY FIXATION SYSTEMS
| Applicant | I.T.S. GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Aug 7, 2013 |
| Received | Jun 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131722
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers.
1. FLS - Foot Locking Plates System, Cancellous Stabilization Open, Classified |
HRS | None listed |
| Mar 20, 2026 | I.T.S. GmbH HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31 Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.