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FDA 510(k)

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture

K-Number: K160854 · 2016-12-19

ApplicantBiomet Manafacturing Corp.
Decision Date2016-12-19
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture is a medical device manufactured by Biomet Manafacturing Corp.. It received FDA 510(k) clearance on 2016-12-19 under approval number K160854. 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 MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture?

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture is a medical device that received FDA 510(k) clearance on 2016-12-19. It is manufactured by Biomet Manafacturing Corp.. The 510(k) number is K160854.

When was MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture approved by the FDA?

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture received FDA 510(k) clearance on 2016-12-19, under approval number K160854.

What company makes MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture?

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture is manufactured by Biomet Manafacturing Corp..

What is the FDA product code for MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture?

The FDA product code for MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture is GAT.

Related Clinical Trials

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Related Devices (Code: GAT)

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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.

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