FDA 510(k)

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture

Номер K: K160854 · 2016-12-19

Дата решения2016-12-19

Код продуктаGAT

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manafacturing Corp.. It received FDA 510(k) clearance on 2016-12-19 under 510(k) number K160854. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

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. The listed applicant is Biomet Manafacturing Corp.. The 510(k) number is K160854.

When did MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture receive FDA 510(k) clearance?

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

Who is the listed applicant for MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture?

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

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GAT)

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.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.

Официальный источник

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