Cleared Traditional

POLARIS SPINAL SYSTEM

K131615 · Biomet Spine (Aka Ebi, LLC) · Orthopedic

Sep 2013

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K131615 is an FDA 510(k) clearance for the POLARIS SPINAL SYSTEM, a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II — Special Controls, product code OSH), submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on September 4, 2013, 93 days after receiving the submission on June 3, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K131615 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2013
Decision Date	September 04, 2013
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.