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FDA 510(k)

Streamline Navigated Instruments

K-Number: K200095 · 2020-06-26

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Decision Date2020-06-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Streamline Navigated Instruments is a medical device manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2020-06-26 under approval number K200095. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Streamline Navigated Instruments?

Streamline Navigated Instruments is a medical device that received FDA 510(k) clearance on 2020-06-26. It is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K200095.

When was Streamline Navigated Instruments approved by the FDA?

Streamline Navigated Instruments received FDA 510(k) clearance on 2020-06-26, under approval number K200095.

What company makes Streamline Navigated Instruments?

Streamline Navigated Instruments is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc..

What is the FDA product code for Streamline Navigated Instruments?

The FDA product code for Streamline Navigated Instruments is OLO.

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

K161876Tritium® Sternal Cable Plate System K152793Unison-C Anterior Cervical Fixation System K170830Unison-C Anterior Cervical Fixation System K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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