Company ยท US
Centerpulse Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2004. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 5 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2004 | K033943 | ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED Centerpulse Orthopedics, Inc. | KWA |
| Sep 15, 2004 | K033634 | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED Centerpulse Orthopedics, Inc. | KWA |
| Aug 27, 2004 | K040947 | DURASUL BIPOLAR Centerpulse Orthopedics, Inc. | KWY |
| Mar 5, 2004 | K033810 | NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM Centerpulse Orthopedics, Inc. | HRY |
| Dec 17, 2003 | K033664 | MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM Centerpulse Orthopedics, Inc. | LZO |
| Oct 24, 2003 | K032348 | CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP Centerpulse Orthopedics, Inc. | LZO |
| Oct 3, 2003 | K030923 | EPSILON DURASUL CONSTRAINED ACETABULAR LINER Centerpulse Orthopedics, Inc. | KWZ |
| Sep 22, 2003 | K032380 | WAGNER CONE PROSTHESIS Centerpulse Orthopedics, Inc. | LZO |
| Jul 14, 2003 | K031183 | TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE Centerpulse Orthopedics, Inc. | JWH |
| Mar 6, 2003 | K030373 | ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM Centerpulse Orthopedics, Inc. | LZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Centerpulse Orthopedics, Inc RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas Terminated |
LZO | K022985 |