Cleared Traditional

Unison-C Anterior Cervical Fixation System

K152793 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic

Jan 2016

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K152793 is an FDA 510(k) clearance for the Unison-C Anterior Cervical Fixation System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on January 19, 2016, 113 days after receiving the submission on September 28, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K152793 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2015
Decision Date	January 19, 2016
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.