FDA 510(k)

AUXILOCK PEEK OPTIMA Clavo de Sutura, AUXILOCK ROTADOR PEEK OPTIMA Clavo de Anclaje

N.º K: K213110 · 2022-12-16

SolicitanteAuxein Medical Private Limited

Fecha de decisión2022-12-16

Código de productoMBI

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K213110. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor?

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K213110.

When did AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor receive FDA 510(k) clearance?

AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor received FDA 510(k) clearance on 2022-12-16, under 510(k) number K213110.

Who is the listed applicant for AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor?

The FDA 510(k) record lists Auxein Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor?

The FDA product code for AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor is MBI.

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Otros registros que enlistan a Auxein Medical Private Limited como solicitante

K221787Auxein's DHS/DCS Plate System K213059Tibia and Fibula System K213018Auxilock GFS Mini, GFS II Large, and GFS Ultimate K213108Humerus & Ulna System K213014Varixis Elbow System K213109Auxilock Draw Tight Suture-Based Anchor

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.