510(k) K100562 ยท JDB Prosthesis, Elbow, Semi-Constrained, Cemented
LATITUDE ELBOW PROSTHESIS
| Applicant | Tornier, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Jun 29, 2010 |
| Received | Mar 1, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100562
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2025 | Tornier, Inc stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained, Cemented Open, Classified |
JDB | None listed |
| Aug 29, 2011 | Tornier, Inc Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA.
The Tornier In. Latitude Elbow Prosthesis Terminated |
JDB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.