The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Comprehensive Convertible Glenoid.
| Device ID | K130390 |
| 510k Number | K130390 |
| Device Name: | COMPREHENSIVE CONVERTIBLE GLENOID |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46580 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46580 -0587 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-15 |
| Decision Date | 2013-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304673816 | K130390 | 000 |
| 00887868343797 | K130390 | 000 |
| 00887868343780 | K130390 | 000 |
| 00887868348563 | K130390 | 000 |
| 00887868348556 | K130390 | 000 |
| 00887868348549 | K130390 | 000 |
| 00887868348525 | K130390 | 000 |
| 00887868348518 | K130390 | 000 |
| 00887868348501 | K130390 | 000 |
| 00887868348495 | K130390 | 000 |
| 00887868348488 | K130390 | 000 |
| 00880304567948 | K130390 | 000 |
| 00880304567955 | K130390 | 000 |
| 00880304673809 | K130390 | 000 |
| 00880304568181 | K130390 | 000 |
| 00880304568174 | K130390 | 000 |
| 00880304568167 | K130390 | 000 |
| 00880304568150 | K130390 | 000 |
| 00880304568143 | K130390 | 000 |
| 00880304568136 | K130390 | 000 |
| 00880304568129 | K130390 | 000 |
| 00880304568112 | K130390 | 000 |
| 00880304568105 | K130390 | 000 |
| 00887868348471 | K130390 | 000 |