FDA 510(k)

Release Laminoplasty Fixation System

Número K: K153735 · 2016-01-21

RequerentePioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Data da decisão2016-01-21

Código do produtoNQW

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Release Laminoplasty Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K153735. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Release Laminoplasty Fixation System?

Release Laminoplasty Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K153735.

When did Release Laminoplasty Fixation System receive FDA 510(k) clearance?

Release Laminoplasty Fixation System received FDA 510(k) clearance on 2016-01-21, under 510(k) number K153735.

Who is the listed applicant for Release Laminoplasty Fixation System?

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

What is the FDA product code for Release Laminoplasty Fixation System?

The FDA product code for Release Laminoplasty Fixation System is NQW.

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