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 |