The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Response 2000 Cemented Hip Stem.
| Device ID | K000432 |
| 510k Number | K000432 |
| Device Name: | RESPONSE 2000 CEMENTED HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Arlene C Saull |
| Correspondent | Arlene C Saull DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-09 |
| Decision Date | 2000-04-24 |
| Summary: | summary |