FDA 510(k)

ExpressBraid Graft Manipulation

K-Number: K163651 · 2017-02-17

Decision Date2017-02-17

Product CodeGAT

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ExpressBraid Graft Manipulation is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K163651. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ExpressBraid Graft Manipulation?

ExpressBraid Graft Manipulation is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K163651.

When did ExpressBraid Graft Manipulation receive FDA 510(k) clearance?

ExpressBraid Graft Manipulation received FDA 510(k) clearance on 2017-02-17, under 510(k) number K163651.

Who is the listed applicant for ExpressBraid Graft Manipulation?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ExpressBraid Graft Manipulation?

The FDA product code for ExpressBraid Graft Manipulation is GAT.

Other records listing Biomet Manufacturing Corp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P010014Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing K230540Patient Specific Planning Solution™ 3D Bone Models K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System K211729Comprehensive® Convertible Glenoid - Vivacit-E Liner K202232Comprehensive Vault Reconstruction System K193038Comprehensive Shoulder System

View all 16 devices →

Related Devices (Code: GAT)

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC K254275HyperSuture All Green Extension LineThreadstone, LLC K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.