FDA 510(k)

Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants

Número K: K221468 · 2023-02-14

Data da decisão2023-02-14

Código do produtoMAI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants 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 2023-02-14 under 510(k) number K221468. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants?

Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants is a medical device that received FDA 510(k) clearance on 2023-02-14. The listed applicant is Acuitive Technologies, Inc.. The 510(k) number is K221468.

When did Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants receive FDA 510(k) clearance?

Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants received FDA 510(k) clearance on 2023-02-14, under 510(k) number K221468.

Who is the listed applicant for Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants?

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 (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants?

The FDA product code for Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants is MAI.

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Outros registros que listam Acuitive Technologies, Inc. como candidato(a)

K240450Citrepore™K232592CITRELOCK® DUO K220833Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL K210239CITRESPLINE and CITRELOCK ACL Implants K203334The Citrefix Knotless Suture Anchor

Dispositivos Relacionados (Código: MAI)

K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc.K260294SF Push-in AnchorSurgical Fusion Technologies GmbH K254055OSSIOfiber® Suture AnchorOSSIO , Ltd.K251680Biosteon® ScrewBiocomposites, Ltd.K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation

Fonte oficial

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