The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Ventix Knotless Anchors.
Device ID | K152262 |
510k Number | K152262 |
Device Name: | Ventix Knotless Anchors |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DR. Warsaw, IN 46581 |
Contact | Jared Cooper |
Correspondent | Jared Cooper BIOMET MANUFACTURING CORP. 56 EAST BELL DR. Warsaw, IN 46581 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-11 |
Decision Date | 2016-03-08 |
Summary: | summary |