The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Corail Amt Dysplasia Hip Prosthesis.
| Device ID | K070554 |
| 510k Number | K070554 |
| Device Name: | DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Kathy Harris |
| Correspondent | Kathy Harris DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KWA |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-27 |
| Decision Date | 2007-09-11 |
| Summary: | summary |