510(k) K093868 ยท HRS Plate, Fixation, Bone
I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM
| Applicant | I.T.S. Implantat-Technologie-Systeme GmbH, Prior Lake MN, US |
| Decision | Substantially Equivalent, Aug 5, 2010 |
| Received | Dec 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093868
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2026 | I.T.S. GmbH I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers.
1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9 Open, Classified |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.