Cleared Special

EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM

K131802 · Depuy Spine, A Johnson & Johnson Company · Orthopedic

Sep 2013

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K131802 is an FDA 510(k) clearance for the EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM, a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II — Special Controls, product code OSH), submitted by Depuy Spine, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on September 12, 2013, 85 days after receiving the submission on June 19, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K131802 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2013
Decision Date	September 12, 2013
Days to Decision	85 days
Submission Type	Special
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.