510(k) K051642 ยท NDF Plate, Fixation, Bone, Non-Spinal, Metallic
FR.O.H. CALCANEUS REPAIR SYSTEM
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Aug 22, 2005 |
| Received | Jun 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60. Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.