The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Dupont Orthopaedics Finger Joint Prosthesis.
Device ID | K970544 |
510k Number | K970544 |
Device Name: | DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS |
Classification | Prosthesis, Finger, Constrained, Polymer |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
Contact | Cherly Hastings |
Correspondent | Cherly Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. 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 | 1997-02-12 |
Decision Date | 1997-09-12 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295017950 | K970544 | 000 |
10603295018001 | K970544 | 000 |
10603295017998 | K970544 | 000 |
10603295017981 | K970544 | 000 |
10603295017974 | K970544 | 000 |
10603295017967 | K970544 | 000 |
10603295017943 | K970544 | 000 |