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 |