MaxBraid BroadBand Suture And Expressbraid BroadBand Graft Manipulation Suture

Suture, Nonabsorbable, Synthetic, Polyethylene

Biomet Manafacturing Corp.

The following data is part of a premarket notification filed by Biomet Manafacturing Corp. with the FDA for Maxbraid Broadband Suture And Expressbraid Broadband Graft Manipulation Suture.

Pre-market Notification Details

• Device ID: K160854
• 510k Number: K160854
• Device Name: MaxBraid BroadBand Suture And Expressbraid BroadBand Graft Manipulation Suture
• Classification: Suture, Nonabsorbable, Synthetic, Polyethylene
• Applicant: Biomet Manafacturing Corp. 56 East Bell Drive PO Box 587 Warsaw, IN 46581
• Contact: Adam Cargill
• Correspondent: Jared Cooper; Biomet Manafacturing 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: 2016-03-28
• Decision Date: 2016-12-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00880304815278	K160854	000
00880304815261	K160854	000
00880304815254	K160854	000
00880304815247	K160854	000