The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Comprehensive Vault Reconstruction System (vrs).
Device ID | K152754 |
510k Number | K152754 |
Device Name: | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) |
Classification | Shoulder Prosthesis, Reverse Configuration |
Applicant | BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
Contact | Patricia Sandborn Beres |
Correspondent | Patricia Sandborn Beres BIOMET MANUFACTURING CORP. 56 BELL DRIVE Warsaw, IN 46580 |
Product Code | PHX |
CFR Regulation Number | 888.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-24 |
Decision Date | 2016-05-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304834026 | K152754 | 000 |
00880304818965 | K152754 | 000 |
00889024563599 | K152754 | 000 |
00880304818934 | K152754 | 000 |
00880304818941 | K152754 | 000 |
00880304826526 | K152754 | 000 |
00880304829473 | K152754 | 000 |
00880304829480 | K152754 | 000 |
00880304829497 | K152754 | 000 |
00880304829503 | K152754 | 000 |
00880304829510 | K152754 | 000 |
00880304829527 | K152754 | 000 |
00880304818958 | K152754 | 000 |