The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy C-stem Amt Hip Prosthesis.
Device ID | K042959 |
510k Number | K042959 |
Device Name: | DEPUY C-STEM AMT HIP PROSTHESIS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Dina L Weissman |
Correspondent | Dina L Weissman DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-27 |
Decision Date | 2004-12-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295060369 | K042959 | 000 |
10603295059615 | K042959 | 000 |
10603295059639 | K042959 | 000 |
10603295059646 | K042959 | 000 |
10603295059653 | K042959 | 000 |
10603295059660 | K042959 | 000 |
10603295059677 | K042959 | 000 |
10603295060291 | K042959 | 000 |
10603295060307 | K042959 | 000 |
10603295060321 | K042959 | 000 |
10603295060338 | K042959 | 000 |
10603295060345 | K042959 | 000 |
10603295060352 | K042959 | 000 |
10603295059608 | K042959 | 000 |