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FDA 510(k)

FIXIT / ComposiTCP Threaded Anchor System

K-Number: K180960 · 2018-07-25

ApplicantS.B.M. Sas Sciences For Bio Materials
Decision Date2018-07-25
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by S.B.M. Sas Sciences For Bio Materials. The 510(k) number is K180960.

When was FIXIT / ComposiTCP Threaded Anchor System approved by the FDA?

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

What company makes FIXIT / ComposiTCP Threaded Anchor System?

FIXIT / ComposiTCP Threaded Anchor System is manufactured by S.B.M. Sas Sciences For Bio Materials.

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

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

Related Clinical Trials

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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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