510(k) K100858 ยท KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,
| Applicant | Lima-Lto S.P.A., Winona Lake IN, US |
| Decision | Substantially Equivalent, Dec 10, 2010 |
| Received | Mar 26, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2015 | Limacorporate S.p.A SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445;
SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm Terminated |
KWT | None listed |
| Sep 2, 2015 | Limacorporate S.p.A SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery. Terminated |
HSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.