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FDA 510(k)

Citregen Tendon Interference Screw and Citrelock

K-Number: K200725 · 2020-10-07

ApplicantAcuitive Technologies
Decision Date2020-10-07
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Citregen Tendon Interference Screw and Citrelock is a medical device manufactured by Acuitive Technologies. It received FDA 510(k) clearance on 2020-10-07 under approval number K200725. 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 Citregen Tendon Interference Screw and Citrelock?

Citregen Tendon Interference Screw and Citrelock is a medical device that received FDA 510(k) clearance on 2020-10-07. It is manufactured by Acuitive Technologies. The 510(k) number is K200725.

When was Citregen Tendon Interference Screw and Citrelock approved by the FDA?

Citregen Tendon Interference Screw and Citrelock received FDA 510(k) clearance on 2020-10-07, under approval number K200725.

What company makes Citregen Tendon Interference Screw and Citrelock?

Citregen Tendon Interference Screw and Citrelock is manufactured by Acuitive Technologies.

What is the FDA product code for Citregen Tendon Interference Screw and Citrelock?

The FDA product code for Citregen Tendon Interference Screw and Citrelock is MAI.

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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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