The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Sigma Cruciate Retaining Porocoat Femoral Components.
Device ID | K062654 |
510k Number | K062654 |
Device Name: | DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS |
Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, 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 | MBH |
CFR Regulation Number | 888.3565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-07 |
Decision Date | 2006-09-29 |
Summary: | summary |