510(k) K142418 ยท HRS Plate, Fixation, Bone
I.T.S. Hand Locking Plates System - HLS
| Applicant | I.T.S. GmbH, Lassinitzhoehe/Graz, AT |
| Decision | Substantially Equivalent, Sep 26, 2014 |
| Received | Aug 28, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers.
1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.