The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Dupont Orthopaedics Finger Joint Prosthesis.
| Device ID | K970544 |
| 510k Number | K970544 |
| Device Name: | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cherly Hastings |
| Correspondent | Cherly Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | KYJ |
| CFR Regulation Number | 888.3230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-12 |
| Decision Date | 1997-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295017950 | K970544 | 000 |
| 10603295018001 | K970544 | 000 |
| 10603295017998 | K970544 | 000 |
| 10603295017981 | K970544 | 000 |
| 10603295017974 | K970544 | 000 |
| 10603295017967 | K970544 | 000 |
| 10603295017943 | K970544 | 000 |