The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Sigma Cr-f Femoral Component.
Device ID | K082500 |
510k Number | K082500 |
Device Name: | DEPUY SIGMA CR-F FEMORAL COMPONENT |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Nancy Friddle |
Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-29 |
Decision Date | 2008-11-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10603295074991 | K082500 | 000 |
10603295074892 | K082500 | 000 |
10603295074908 | K082500 | 000 |
10603295074939 | K082500 | 000 |
10603295074830 | K082500 | 000 |
10603295074847 | K082500 | 000 |
10603295074854 | K082500 | 000 |
10603295074861 | K082500 | 000 |
10603295074878 | K082500 | 000 |
10603295074922 | K082500 | 000 |
10603295074946 | K082500 | 000 |
10603295074953 | K082500 | 000 |
10603295074960 | K082500 | 000 |
10603295074977 | K082500 | 000 |
10603295074984 | K082500 | 000 |
10603295074885 | K082500 | 000 |