Cleared Traditional

POLARIS SPINAL SYSTEM

K133746 · Biomet Spine (Aka Ebi, LLC) · Orthopedic

Mar 2014

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K133746 is an FDA 510(k) clearance for the POLARIS SPINAL SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on March 12, 2014, 93 days after receiving the submission on December 9, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K133746 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2013
Decision Date	March 12, 2014
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.