The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Corail Amt Hip Prosthesis.
| Device ID | K042992 |
| 510k Number | K042992 |
| Device Name: | CORAIL AMT HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Nancy S Friddle |
| Correspondent | Nancy S Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWA |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295257998 | K042992 | 000 |
| 10603295168751 | K042992 | 000 |
| 10603295168768 | K042992 | 000 |
| 10603295168775 | K042992 | 000 |
| 10603295168782 | K042992 | 000 |
| 10603295168799 | K042992 | 000 |
| 10603295168805 | K042992 | 000 |
| 10603295168812 | K042992 | 000 |
| 10603295168829 | K042992 | 000 |
| 10603295168744 | K042992 | 000 |
| 10603295168737 | K042992 | 000 |
| 10603295168720 | K042992 | 000 |
| 10603295168645 | K042992 | 000 |
| 10603295168652 | K042992 | 000 |
| 10603295168669 | K042992 | 000 |
| 10603295168676 | K042992 | 000 |
| 10603295168683 | K042992 | 000 |
| 10603295168690 | K042992 | 000 |
| 10603295168706 | K042992 | 000 |
| 10603295168713 | K042992 | 000 |
| 10603295168836 | K042992 | 000 |
| 10603295168843 | K042992 | 000 |
| 10603295168850 | K042992 | 000 |
| 10603295258018 | K042992 | 000 |
| 10603295258025 | K042992 | 000 |
| 10603295258032 | K042992 | 000 |
| 10603295258049 | K042992 | 000 |
| 10603295258056 | K042992 | 000 |
| 10603295258063 | K042992 | 000 |
| 10603295258070 | K042992 | 000 |
| 10603295258087 | K042992 | 000 |
| 10603295258001 | K042992 | 000 |
| 10603295168959 | K042992 | 000 |
| 10603295168942 | K042992 | 000 |
| 10603295168867 | K042992 | 000 |
| 10603295168874 | K042992 | 000 |
| 10603295168881 | K042992 | 000 |
| 10603295168898 | K042992 | 000 |
| 10603295168904 | K042992 | 000 |
| 10603295168911 | K042992 | 000 |
| 10603295168928 | K042992 | 000 |
| 10603295168935 | K042992 | 000 |
| 10603295258094 | K042992 | 000 |