FDA 510(k)

Republic Spine Restore Cervical Interbody Fusion System

Número K: K190889 · 2019-06-19

Data da decisão2019-06-19

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Republic Spine Restore Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Republic Spine, LLC. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K190889. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Republic Spine Restore Cervical Interbody Fusion System?

Republic Spine Restore Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Republic Spine, LLC. The 510(k) number is K190889.

When did Republic Spine Restore Cervical Interbody Fusion System receive FDA 510(k) clearance?

Republic Spine Restore Cervical Interbody Fusion System received FDA 510(k) clearance on 2019-06-19, under 510(k) number K190889.

Who is the listed applicant for Republic Spine Restore Cervical Interbody Fusion System?

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

What is the FDA product code for Republic Spine Restore Cervical Interbody Fusion System?

The FDA product code for Republic Spine Restore Cervical Interbody Fusion System is ODP.

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Outros registros que listam Republic Spine, LLC como candidato(a)

K223096Dark Star Deformity Pedicle Screw System K212028Dark Star Navigation Instrument System K201420Republic Spine Dark Star Spinal System K190398Republic Spine Restore Intervertebral Body Fusion System K181495Republic Spine Dark Star Spinal System

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.

Fonte oficial

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