The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Cannulated Bone Screw.
Device ID | K893512 |
510k Number | K893512 |
Device Name: | DEPUY CANNULATED BONE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Melinda A Wright |
Correspondent | Melinda A Wright DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-05 |
Decision Date | 1989-08-21 |