FDA 510(k)

Streamline MIS Spinal Fixation System

Número K: K192396 · 2019-11-26

RequerentePioneer Surgical Technology, Inc.

Data da decisão2019-11-26

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Streamline MIS Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc.. It received FDA 510(k) clearance on 2019-11-26 under 510(k) number K192396. 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 Streamline MIS Spinal Fixation System?

Streamline MIS Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Pioneer Surgical Technology, Inc.. The 510(k) number is K192396.

When did Streamline MIS Spinal Fixation System receive FDA 510(k) clearance?

Streamline MIS Spinal Fixation System received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192396.

Who is the listed applicant for Streamline MIS Spinal Fixation System?

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

What is the FDA product code for Streamline MIS Spinal Fixation System?

The FDA product code for Streamline MIS Spinal Fixation System is NKB.

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Dispositivos Relacionados (Código: NKB)

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Fonte oficial

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