510(k) K070359 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
DEPUY ASR TAPER SLEEVE ADAPTER
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 6, 2007 |
| Received | Feb 7, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 11/13 -3, DEPUY ASR TAPER SLEEVE ADAPTER, ASR MODULAR ACETABULAR CUP SYSTEM, TAPER SLEEVE ADAPTERS (SPECIAL).
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal a Terminated |
KWA | None listed |
| Mar 24, 2011 | Depuy Orthopaedics, Inc. ASR TAP SLV ADAP 12/14 -1, DEPUY ASR TAPER SLEEVE ADAPTER, ASR ACETABULAR CUP SYSTEM, TAPER SLEEVE ADAPTERS (SPECIAL).
The DePuy ASR Acetabular Cup System is comprised of a one-piece metal acetabula Terminated |
KWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.