510(k) K983136 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
DEPUY LUSTER STEM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 25, 1998 |
| Received | Sep 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983136
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 1
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 2
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 3
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 4
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 5
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 6
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 7
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 8
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors Terminated |
JDI | None listed |
| Jun 29, 2012 | DePuy Orthopaedics, Inc. LUSTER HIP SZ 10
Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protector Terminated |
JDI | None listed |
| Sep 21, 2005 | Linvatec Corp. Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6120A QTY 1 BIO-ANCHOR, PRE-LOADED 3.5mm x 10.5 mm ***STERILE ***Linvatec, LINVATEC CORPORATION LAR Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.