510(k) K101761 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Sep 21, 2010 |
| Received | Jun 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2014 | Exactech, Inc. ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630.
The Exactech Novation InteGrip Acetabular Augments are indicated for use in Terminated |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.