FDA 510(k)

Calvary Spine Pedicle Screw System

Número K: K201568 · 2020-11-12

Data da decisão2020-11-12

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Calvary Spine Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Calvary Spine, LLC. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K201568. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Calvary Spine Pedicle Screw System?

Calvary Spine Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Calvary Spine, LLC. The 510(k) number is K201568.

When did Calvary Spine Pedicle Screw System receive FDA 510(k) clearance?

Calvary Spine Pedicle Screw System received FDA 510(k) clearance on 2020-11-12, under 510(k) number K201568.

Who is the listed applicant for Calvary Spine Pedicle Screw System?

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

What is the FDA product code for Calvary Spine Pedicle Screw System?

The FDA product code for Calvary Spine Pedicle Screw System is NKB.

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