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 |