Cleared Traditional

IMPLANET SPINE SYSTEM

K132303 · Implanet, S.A. · Orthopedic

Oct 2013

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K132303 is an FDA 510(k) clearance for the IMPLANET SPINE SYSTEM, a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II — Special Controls, product code OSH), submitted by Implanet, S.A. (Philedelphia, US). The FDA issued a Cleared decision on October 10, 2013, 78 days after receiving the submission on July 24, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K132303 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2013
Decision Date	October 10, 2013
Days to Decision	78 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.