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FDA 510(k)

Unison-C Anterior Cervical Fixation System

K-Number: K170830 · 2017-06-28

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Decision Date2017-06-28
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Unison-C Anterior Cervical Fixation System is a medical device manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. It received FDA 510(k) clearance on 2017-06-28 under approval number K170830. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unison-C Anterior Cervical Fixation System?

Unison-C Anterior Cervical Fixation System is a medical device that received FDA 510(k) clearance on 2017-06-28. It is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K170830.

When was Unison-C Anterior Cervical Fixation System approved by the FDA?

Unison-C Anterior Cervical Fixation System received FDA 510(k) clearance on 2017-06-28, under approval number K170830.

What company makes Unison-C Anterior Cervical Fixation System?

Unison-C Anterior Cervical Fixation System is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc..

What is the FDA product code for Unison-C Anterior Cervical Fixation System?

The FDA product code for Unison-C Anterior Cervical Fixation System is OVE.

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

K161876Tritium® Sternal Cable Plate System K152793Unison-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 K200095Streamline Navigated Instruments

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

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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