FDA 510(k)

FIXIT / ComposiTCP Threaded Anchor System

Número K: K180960 · 2018-07-25

RequerenteS.B.M. Sas Sciences For Bio Materials

Data da decisão2018-07-25

Código do produtoMAI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FIXIT / ComposiTCP Threaded Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is S.B.M. Sas Sciences For Bio Materials. It received FDA 510(k) clearance on 2018-07-25 under 510(k) number K180960. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FIXIT / ComposiTCP Threaded Anchor System?

FIXIT / ComposiTCP Threaded Anchor System is a medical device that received FDA 510(k) clearance on 2018-07-25. The listed applicant is S.B.M. Sas Sciences For Bio Materials. The 510(k) number is K180960.

When did FIXIT / ComposiTCP Threaded Anchor System receive FDA 510(k) clearance?

FIXIT / ComposiTCP Threaded Anchor System received FDA 510(k) clearance on 2018-07-25, under 510(k) number K180960.

Who is the listed applicant for FIXIT / ComposiTCP Threaded Anchor System?

The FDA 510(k) record lists S.B.M. Sas Sciences For Bio Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXIT / ComposiTCP Threaded Anchor System?

The FDA product code for FIXIT / ComposiTCP Threaded Anchor System is MAI.

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