The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Segmental Revision System (srs).
Device ID | K173411 |
510k Number | K173411 |
Device Name: | Comprehensive Segmental Revision System (SRS) |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46580 |
Contact | Patricia Sandborn Beres |
Correspondent | Patricia Sandborn Beres Biomet Manufacturing Corp. 56 East Bell Drive Warsaw, IN 46580 |
Product Code | PHX |
Subsequent Product Code | JDC |
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 | 2017-11-01 |
Decision Date | 2018-02-08 |
Summary: | summary |