The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Reverse Shoulder Humeral Tray.
Device ID | K113069 |
510k Number | K113069 |
Device Name: | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
Contact | Patricia S Beres |
Correspondent | Patricia S Beres BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-10-17 |
Decision Date | 2012-01-11 |
Summary: | summary |