Cleared Traditional

OLYMPIC Posterior Spinal Fixation System

K153446 · Astura Medical · Orthopedic

Apr 2016

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K153446 is an FDA 510(k) clearance for the OLYMPIC Posterior Spinal Fixation System, a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II — Special Controls, product code OSH), submitted by Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on April 8, 2016, 133 days after receiving the submission on November 27, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K153446 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 2015
Decision Date	April 08, 2016
Days to Decision	133 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.