FDA 510(k)

Parafuso de Sutura AUTOLOCK PEEK OPTIMA, Parafuso de Ancoragem AUTOLOCK ROTADOR PEEK OPTIMA

Número K: K213110 · 2022-12-16

RequerenteAuxein Medical Private Limited

Data da decisão2022-12-16

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Auxein Medical Private Limited como candidato(a)

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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Fonte oficial

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