Cleared Traditional

PASS LP SPINAL SYSTEM

K132574 · Medicrea International · Orthopedic

Nov 2013

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K132574 is an FDA 510(k) clearance for the PASS LP SPINAL SYSTEM, a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II — Special Controls, product code OSH), submitted by Medicrea International (Neyron, FR). The FDA issued a Cleared decision on November 8, 2013, 84 days after receiving the submission on August 16, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K132574 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2013
Decision Date	November 08, 2013
Days to Decision	84 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.