The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Reverse Shoulder Screws.
| Device ID | K132239 |
| 510k Number | K132239 |
| Device Name: | COMPREHENSIVE REVERSE SHOULDER SCREWS |
| 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 |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2013-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304673045 | K132239 | 000 |
| 00880304469907 | K132239 | 000 |
| 00887868504617 | K132239 | 000 |
| 00887868504761 | K132239 | 000 |
| 00887868513084 | K132239 | 000 |
| 00887868504624 | K132239 | 000 |
| 00887868504631 | K132239 | 000 |
| 00887868504648 | K132239 | 000 |
| 00887868504563 | K132239 | 000 |
| 00887868504662 | K132239 | 000 |
| 00880304469594 | K132239 | 000 |
| 00887868471209 | K132239 | 000 |
| 00887868469978 | K132239 | 000 |
| 00880304447820 | K132239 | 000 |
| 00880304469839 | K132239 | 000 |