The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Expressbraid Graft Manipulation.
Device ID | K152868 |
510k Number | K152868 |
Device Name: | ExpressBraid Graft Manipulation |
Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IL 46581 |
Contact | Adam Cargill |
Correspondent | Adam Cargill BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IL 46581 |
Product Code | GAT |
CFR Regulation Number | 878.5000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-30 |
Decision Date | 2016-02-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00880304566712 | K152868 | 000 |
00880304566705 | K152868 | 000 |
00880304566675 | K152868 | 000 |
00880304566668 | K152868 | 000 |
70887868462565 | K152868 | 000 |
00887868462689 | K152868 | 000 |
00887868462672 | K152868 | 000 |
70887868462558 | K152868 | 000 |