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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 the device name listed in this FDA 510(k) record. The listed applicant is Acuitive Technologies. It received FDA 510(k) clearance on 2020-10-07 under 510(k) 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. The listed applicant is Acuitive Technologies. The 510(k) number is K200725.

When did Citregen Tendon Interference Screw and Citrelock receive FDA 510(k) clearance?

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

Who is the listed applicant for Citregen Tendon Interference Screw and Citrelock?

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

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.

Related Clinical Trials

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NCT02918734Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference ScrewsRECRUITING

Other records listing Acuitive Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240450Citrepore™K232592CITRELOCK® DUOK221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL ImplantsK220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACLK210239CITRESPLINE and CITRELOCK ACL ImplantsK203334The Citrefix Knotless Suture Anchor

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Related Devices (Code: MAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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