The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Converge Reti-lock Multi-hole Reinforcement Cup.
| Device ID | K032348 |
| 510k Number | K032348 |
| Device Name: | CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Robert M Wolfarth |
| Correspondent | Robert M Wolfarth CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWA |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-30 |
| Decision Date | 2003-10-24 |
| Summary: | summary |