FDA 510(k)

ChoiceSpine TigerShark™ M, Modular Interbody System

Número K: K220953 · 2022-09-13

Data da decisão2022-09-13

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ChoiceSpine TigerShark™ M, Modular Interbody 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 2022-09-13 under 510(k) number K220953. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ChoiceSpine TigerShark™ M, Modular Interbody System?

ChoiceSpine TigerShark™ M, Modular Interbody System is a medical device that received FDA 510(k) clearance on 2022-09-13. The listed applicant is Choice Spine, LLC. The 510(k) number is K220953.

When did ChoiceSpine TigerShark™ M, Modular Interbody System receive FDA 510(k) clearance?

ChoiceSpine TigerShark™ M, Modular Interbody System received FDA 510(k) clearance on 2022-09-13, under 510(k) number K220953.

Who is the listed applicant for ChoiceSpine TigerShark™ M, Modular Interbody 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 TigerShark™ M, Modular Interbody System?

The FDA product code for ChoiceSpine TigerShark™ M, Modular Interbody System is MAX.

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Fonte oficial

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