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FDA 510(k)

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL

K-Number: K220833 · 2022-11-04

ApplicantAcuitive Technologies, Inc.
Decision Date2022-11-04
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is a medical device manufactured by Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2022-11-04 under approval number K220833. 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, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL?

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Acuitive Technologies, Inc.. The 510(k) number is K220833.

When was Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL approved by the FDA?

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL received FDA 510(k) clearance on 2022-11-04, under approval number K220833.

What company makes Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL?

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is manufactured by Acuitive Technologies, Inc..

What is the FDA product code for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL?

The FDA product code for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is MAI.

Other Devices by Acuitive Technologies, Inc.

K210239CITRESPLINE and CITRELOCK ACL Implants K203334The Citrefix Knotless Suture Anchor K232592CITRELOCK® DUO K221468Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants K240450Citrepore™

Related Devices (Code: MAI)

K161174Nanova Interference ScrewNanova Biomaterials, Inc. K160804INTRAFIX(TM) Advance Tibial Fastener SystemMedos International SARL K151342Arthrex SwiveLock AnchorsArthrex, Inc. K170868FIXIT Threaded Anchor SystemS.B.M Sas Science For Bio Materials K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL K171592CrossFT™ Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation

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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