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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 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.

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. 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.

Other records listing Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) as applicant

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech 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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