FDA 510(k)

ChoiceSpine Tiger Shark Cervical Spacer System

Número K: K201643 · 2020-12-22

Data da decisão2020-12-22

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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

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

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Dispositivos Relacionados (Código: ODP)

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Fonte oficial

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