FDA 510(k)

ORION Spinal System

Número K: K190600 · 2020-08-18

Data da decisão2020-08-18

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

ORION Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Orion Biotech, Inc.. It received FDA 510(k) clearance on 2020-08-18 under 510(k) number K190600. 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 ORION Spinal System?

ORION Spinal System is a medical device that received FDA 510(k) clearance on 2020-08-18. The listed applicant is Orion Biotech, Inc.. The 510(k) number is K190600.

When did ORION Spinal System receive FDA 510(k) clearance?

ORION Spinal System received FDA 510(k) clearance on 2020-08-18, under 510(k) number K190600.

Who is the listed applicant for ORION Spinal System?

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

What is the FDA product code for ORION Spinal System?

The FDA product code for ORION Spinal System is NKB.

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