FDA 510(k)

ChoiceSpine Tiger Shark Cervical Spacer System

N.º K: K201643 · 2020-12-22

Fecha de decisión2020-12-22

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

ChoiceSpine Tiger Shark Cervical Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Choice Spine, LLC. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K201643. 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 ChoiceSpine Tiger Shark Cervical Spacer System?

ChoiceSpine Tiger Shark Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Choice Spine, LLC. The 510(k) number is K201643.

When did ChoiceSpine Tiger Shark Cervical Spacer System receive FDA 510(k) clearance?

ChoiceSpine Tiger Shark Cervical Spacer System received FDA 510(k) clearance on 2020-12-22, under 510(k) number K201643.

Who is the listed applicant for ChoiceSpine Tiger Shark Cervical Spacer System?

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

What is the FDA product code for ChoiceSpine Tiger Shark Cervical Spacer System?

The FDA product code for ChoiceSpine Tiger Shark Cervical Spacer System is ODP.

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Otros registros que enlistan a Choice Spine, LLC como solicitante

K223869ChoiceSpine Blackhawk Ti Cervical Spacer System K220953ChoiceSpine TigerShark™ M, Modular Interbody System K220024ChoiceSpine Navigation System K211449Triton™ Sacroiliac Joint Fixation System K203311ChoiceSpine Blackhawk Ti Cervical Spacer System K203561ChoiceSpine Navigation System

Ver todos los 9 dispositivos →

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

Ver en la base de datos de la FDA →

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