FDA 510(k)

Streamline OCT Occipito-Cervico-Thoracic System

Número K: K161498 · 2016-08-22

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

Data da decisão2016-08-22

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Streamline OCT Occipito-Cervico-Thoracic 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 2016-08-22 under 510(k) number K161498. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Streamline OCT Occipito-Cervico-Thoracic System?

Streamline OCT Occipito-Cervico-Thoracic System is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K161498.

When did Streamline OCT Occipito-Cervico-Thoracic System receive FDA 510(k) clearance?

Streamline OCT Occipito-Cervico-Thoracic System received FDA 510(k) clearance on 2016-08-22, under 510(k) number K161498.

Who is the listed applicant for Streamline OCT Occipito-Cervico-Thoracic 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 Streamline OCT Occipito-Cervico-Thoracic System?

The FDA product code for Streamline OCT Occipito-Cervico-Thoracic System is NKG.

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Fonte oficial

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