The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Modification To Depuy Delta Xtend Reverse Shoulder System.
Device ID | K081620 |
510k Number | K081620 |
Device Name: | MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM |
Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Rhonda Myer |
Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | KWS |
Subsequent Product Code | HSD |
Subsequent Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-09 |
Decision Date | 2008-06-30 |
Summary: | summary |