The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy C-stem System.
Device ID | K003421 |
510k Number | K003421 |
Device Name: | DEPUY C-STEM SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Marcia J Arentz |
Correspondent | Marcia J Arentz 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 | 2000-11-03 |
Decision Date | 2000-12-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295236849 | K003421 | 000 |