The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Bio-modular Reverse Sholder.
Device ID | K093803 |
510k Number | K093803 |
Device Name: | BIO-MODULAR REVERSE SHOLDER |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
Contact | Patricia Sandborn Beres |
Correspondent | Patricia Sandborn Beres BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-11 |
Decision Date | 2010-10-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304591219 | K093803 | 000 |
00880304506930 | K093803 | 000 |
00887868254062 | K093803 | 000 |