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FDA 510(k)

CITRESPLINE and CITRELOCK ACL Implants

K-Number: K210239 · 2021-02-24

ApplicantAcuitive Technologies, Inc.
Decision Date2021-02-24
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CITRESPLINE and CITRELOCK ACL Implants is a medical device manufactured by Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2021-02-24 under approval number K210239. 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 CITRESPLINE and CITRELOCK ACL Implants?

CITRESPLINE and CITRELOCK ACL Implants is a medical device that received FDA 510(k) clearance on 2021-02-24. It is manufactured by Acuitive Technologies, Inc.. The 510(k) number is K210239.

When was CITRESPLINE and CITRELOCK ACL Implants approved by the FDA?

CITRESPLINE and CITRELOCK ACL Implants received FDA 510(k) clearance on 2021-02-24, under approval number K210239.

What company makes CITRESPLINE and CITRELOCK ACL Implants?

CITRESPLINE and CITRELOCK ACL Implants is manufactured by Acuitive Technologies, Inc..

What is the FDA product code for CITRESPLINE and CITRELOCK ACL Implants?

The FDA product code for CITRESPLINE and CITRELOCK ACL Implants is MAI.

Other Devices by Acuitive Technologies, Inc.

K203334The Citrefix Knotless Suture Anchor K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL 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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