510(k) K083116 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
VERSAFIT CUP DOUBLE MOBILITY SYSTEM
| Applicant | Medacta International S.A., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 7, 2009 |
| Received | Oct 21, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083116
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2013 | Medacta Usa Inc Versafitcup Impacting Ring
Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.2 Terminated |
MEH | None listed |
| Jun 30, 2011 | Medacta Usa Inc Product Brand Name: Versafitcup Double Mobility Liner Inserter
Product Generic Name: Versafitcup Double Mobility Liner Inserter
Model Number: 01.26.10.0018
The hip prosthesis is designed for cement Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.