The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Porous Coated Comprehensive Fracture Stems.
| Device ID | K140652 |
| 510k Number | K140652 |
| Device Name: | POROUS COATED COMPREHENSIVE FRACTURE STEMS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Contact | Brian Kincaid |
| Correspondent | Brian Kincaid BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE Warsaw, IN 46582 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-14 |
| Decision Date | 2014-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304591578 | K140652 | 000 |
| 00880304591561 | K140652 | 000 |
| 00880304591554 | K140652 | 000 |
| 00880304591547 | K140652 | 000 |
| 00880304591530 | K140652 | 000 |
| 00880304591523 | K140652 | 000 |