The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy C-stem Amt.
Device ID | K082239 |
510k Number | K082239 |
Device Name: | DEPUY C-STEM AMT |
Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
Contact | Rhonda Myer |
Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582 |
Product Code | KWA |
Subsequent Product Code | JDI |
Subsequent Product Code | LPH |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-07 |
Decision Date | 2008-08-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295060284 | K082239 | 000 |
10603295059592 | K082239 | 000 |