FDA 510(k)

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

N.º K: K220833 · 2022-11-04

Fecha de decisión2022-11-04

Código de productoMAI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL is the device name listed in this FDA 510(k) record. The listed applicant is Acuitive Technologies, Inc.. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K220833. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Acuitive Technologies, Inc.. The 510(k) number is K220833.

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

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

Who is the listed applicant for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL?

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

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.

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Otros registros que enlistan a Acuitive Technologies, Inc. como solicitante

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

Dispositivos relacionados (Código: MAI)

K262357Anclajes de Sutura Arthrex Bioabsorbibles PushLockArthrex, Inc.K253931Anclajes de Sutura Arthrex Bioabsorbibles PushLockArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbH K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

Fuente oficial

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