The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Expressbraid Graft Manipulation.
Device ID | K163651 |
510k Number | K163651 |
Device Name: | ExpressBraid Graft Manipulation |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | Biomet Manufacturing Corp. 56 East Bell Drive PO Box 587 Warsaw, IN 46581 |
Contact | Vinay Bhal |
Correspondent | Vinay Bhal Biomet Manufacturing Corp. 56 East Bell Drive PO Box 587 Warsaw, IN 46581 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-23 |
Decision Date | 2017-02-17 |
Summary: | summary |