The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Cannulated Cross Pin Screw System.
| Device ID | K963973 |
| 510k Number | K963973 |
| Device Name: | DEPUY CANNULATED CROSS PIN SCREW SYSTEM |
| Classification | Pin, Fixation, Threaded |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Arlene Saull |
| Correspondent | Arlene Saull DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-03 |
| Decision Date | 1996-12-16 |
| Summary: | summary |