The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Asr Taper Sleeve Adapter.
| Device ID | K070359 |
| 510k Number | K070359 |
| Device Name: | DEPUY ASR TAPER SLEEVE ADAPTER |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46582 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-07 |
| Decision Date | 2007-03-06 |
| Summary: | summary |