FDA 510(k)

Velofix(tm) Interbody Fusion System

N.º K: K171749 · 2017-07-13

Fecha de decisión2017-07-13

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Velofix(tm) Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2017-07-13 under 510(k) number K171749. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Velofix(tm) Interbody Fusion System?

Velofix(tm) Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-07-13. The listed applicant is U&I Corporation. The 510(k) number is K171749.

When did Velofix(tm) Interbody Fusion System receive FDA 510(k) clearance?

Velofix(tm) Interbody Fusion System received FDA 510(k) clearance on 2017-07-13, under 510(k) number K171749.

Who is the listed applicant for Velofix(tm) Interbody Fusion System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Velofix(tm) Interbody Fusion System?

The FDA product code for Velofix(tm) Interbody Fusion System is ODP.

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Otros registros que enlistan a U&I Corporation como solicitante

K220147Aspiron S ACP System K210573Velofix SA Cervical Cage K183243Velofix TLIF Cage K190067Velofix Interbody Fusion System K190053SECULOK™ ACP System K181824CBT Screw Fixation System

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Dispositivos relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fuente oficial

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