FDA 510(k)

Origin™ Anterior Cervical Plate System

K-Nummer: K193494 · 2020-04-06

AntragstellerOrthopaedic & Spine Development

Entscheidungsdatum2020-04-06

ProduktcodeKWQ

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

Origin™ Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic & Spine Development. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K193494. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Origin™ Anterior Cervical Plate System?

Origin™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Orthopaedic & Spine Development. The 510(k) number is K193494.

When did Origin™ Anterior Cervical Plate System receive FDA 510(k) clearance?

Origin™ Anterior Cervical Plate System received FDA 510(k) clearance on 2020-04-06, under 510(k) number K193494.

Who is the listed applicant for Origin™ Anterior Cervical Plate System?

The FDA 510(k) record lists Orthopaedic & Spine Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Origin™ Anterior Cervical Plate System?

The FDA product code for Origin™ Anterior Cervical Plate System is KWQ.

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Verwandte Geräte (Code: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Vorderes Halsplatten-SystemZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

Offizielle Quelle

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