Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Unison-C Anterior Cervical Fixation System

K-Number: K152793 · 2016-01-19

ApplicantPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
Decision Date2016-01-19
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 2016-01-19 under approval number K152793. 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 2016-01-19. It is manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K152793.

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

Unison-C Anterior Cervical Fixation System received FDA 510(k) clearance on 2016-01-19, under approval number K152793.

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.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING

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

K161876Tritium® Sternal Cable Plate 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 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.

↑