FDA 510(k)

MTF Pre-Sutured Tendon

Номер K: K181633 · 2019-03-15

ЗаявительMusculoskeletal Transplant Foundation

Дата решения2019-03-15

Код продуктаGAT

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

MTF Pre-Sutured Tendon is the device name listed in this FDA 510(k) record. The listed applicant is Musculoskeletal Transplant Foundation. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K181633. 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 MTF Pre-Sutured Tendon?

MTF Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Musculoskeletal Transplant Foundation. The 510(k) number is K181633.

When did MTF Pre-Sutured Tendon receive FDA 510(k) clearance?

MTF Pre-Sutured Tendon received FDA 510(k) clearance on 2019-03-15, under 510(k) number K181633.

Who is the listed applicant for MTF Pre-Sutured Tendon?

The FDA 510(k) record lists Musculoskeletal Transplant Foundation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTF Pre-Sutured Tendon?

The FDA product code for MTF Pre-Sutured Tendon 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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