FDA 510(k)

ShurFit 2C Lumbar Interbody Fusion System

Número K: K171657 · 2017-08-11

Data da decisão2017-08-11

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ShurFit 2C Lumbar Interbody Fusion 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 2017-08-11 under 510(k) number K171657. 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 2C Lumbar Interbody Fusion System?

ShurFit 2C Lumbar Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2017-08-11. The listed applicant is Precision Spine, Inc.. The 510(k) number is K171657.

When did ShurFit 2C Lumbar Interbody Fusion System receive FDA 510(k) clearance?

ShurFit 2C Lumbar Interbody Fusion System received FDA 510(k) clearance on 2017-08-11, under 510(k) number K171657.

Who is the listed applicant for ShurFit 2C Lumbar Interbody Fusion 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 2C Lumbar Interbody Fusion System?

The FDA product code for ShurFit 2C Lumbar Interbody Fusion System is MAX.

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Fonte oficial

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