FDA 510(k)

MTF Pre-Sutured Tendon

N.º K: K181633 · 2019-03-15

SolicitanteMusculoskeletal Transplant Foundation

Fecha de decisión2019-03-15

Código de productoGAT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Fuente oficial

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