510(k) K132158 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
NOVOHIP TOTAL HIP SYSTEM
| Applicant | Novosource, Inc., Dayton OH, US |
| Decision | Substantially Equivalent, Feb 21, 2014 |
| Received | Jul 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2024 | Novosource, LLC NovoHip Biolox Ball Head 32mmL
Ref: 1345-2803
NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including fem Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.