The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Modification To Depuy Neuflex Pip Finger.
| Device ID | K083107 |
| 510k Number | K083107 |
| Device Name: | MODIFICATION TO DEPUY NEUFLEX PIP FINGER |
| Classification | Prosthesis, Finger, Constrained, Polymer |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE 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 | 2008-10-20 |
| Decision Date | 2009-02-09 |
| Summary: | summary |