The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Total Elbow System.
Device ID | K992656 |
510k Number | K992656 |
Device Name: | DEPUY TOTAL ELBOW SYSTEM |
Classification | Prosthesis, Elbow, Constrained, Cemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Janet G Johnson |
Correspondent | Janet G Johnson DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | JDC |
CFR Regulation Number | 888.3150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-08-09 |
Decision Date | 1999-11-05 |
Summary: | summary |