The following data is part of a premarket notification filed by Depuy(ireland) with the FDA for Delta Xtend Revers Shoulder System.
Device ID | K192448 |
510k Number | K192448 |
Device Name: | Delta Xtend Revers Shoulder System |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | DePuy(Ireland) Loughbeg Ringaskiddy Co.cork Munster, IE |
Contact | Ashley Goncalo |
Correspondent | Ashley Goncalo DePuy Orthopaedies, Inc. 700 Orthopaedies Dr. Warsaw, IN 46582 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-09-06 |
Decision Date | 2019-10-04 |