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FDA 510(k)

Streamline OCT Occipito-Cervico-Thoracic System

K-Number: K161498 · 2016-08-22

ApplicantPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Decision Date2016-08-22
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Streamline OCT Occipito-Cervico-Thoracic System is a medical device manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2016-08-22 under approval number K161498. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K161498.

When was Streamline OCT Occipito-Cervico-Thoracic System approved by the FDA?

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

What company makes Streamline OCT Occipito-Cervico-Thoracic System?

Streamline OCT Occipito-Cervico-Thoracic System is manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.).

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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Other Devices by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

K153735Release Laminoplasty Fixation System K172139Streamline OCT Occipito-Cervico-Thoracic System K183060CervAlign™ Anterior Cervical Plate System K201497EVOS Cabling System K193468Tritium Sternal Cable Plate System K192800Streamline TL Spinal Fixation System

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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