FDA 510(k)

ShurFit Lumbar Interbody System

Número K: K212075 · 2021-12-08

Data da decisão2021-12-08

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ShurFit Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine, Inc.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K212075. 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 ShurFit Lumbar Interbody System?

ShurFit Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Precision Spine, Inc.. The 510(k) number is K212075.

When did ShurFit Lumbar Interbody System receive FDA 510(k) clearance?

ShurFit Lumbar Interbody System received FDA 510(k) clearance on 2021-12-08, under 510(k) number K212075.

Who is the listed applicant for ShurFit Lumbar Interbody System?

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

What is the FDA product code for ShurFit Lumbar Interbody System?

The FDA product code for ShurFit Lumbar Interbody System is MAX.

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Fonte oficial

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