FDA 510(k)

Gemini-C Hybrid Cervical Interbody System

N.º K: K170844 · 2017-07-03

Fecha de decisión2017-07-03

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Gemini-C Hybrid Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Osseus Fusion Systems, LLC. It received FDA 510(k) clearance on 2017-07-03 under 510(k) number K170844. 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 Gemini-C Hybrid Cervical Interbody System?

Gemini-C Hybrid Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2017-07-03. The listed applicant is Osseus Fusion Systems, LLC. The 510(k) number is K170844.

When did Gemini-C Hybrid Cervical Interbody System receive FDA 510(k) clearance?

Gemini-C Hybrid Cervical Interbody System received FDA 510(k) clearance on 2017-07-03, under 510(k) number K170844.

Who is the listed applicant for Gemini-C Hybrid Cervical Interbody System?

The FDA 510(k) record lists Osseus Fusion Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gemini-C Hybrid Cervical Interbody System?

The FDA product code for Gemini-C Hybrid Cervical Interbody System is ODP.

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Otros registros que enlistan a Osseus Fusion Systems, LLC como solicitante

K213590Blue Topaz Sacroiliac Screw System K181347Aries® Lumbar Interbodies K160522White Pearl Preferred Angle Anterior Cervical Plate

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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