The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Neuflex Pip Finger.
| Device ID | K001922 |
| 510k Number | K001922 |
| Device Name: | DEPUY NEUFLEX PIP FINGER |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 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 | 2000-06-23 |
| Decision Date | 2000-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295017936 | K001922 | 000 |
| 10603295017929 | K001922 | 000 |
| 10603295017912 | K001922 | 000 |
| 10603295017905 | K001922 | 000 |
| 10603295017899 | K001922 | 000 |