Cleared Traditional

PASS LP Spinal System

K162786 · Medicrea International SA · Orthopedic

Jan 2017

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K162786 is an FDA 510(k) clearance for the PASS LP Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medicrea International SA (Neyron, FR). The FDA issued a Cleared decision on January 25, 2017, 114 days after receiving the submission on October 3, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K162786 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 03, 2016
Decision Date	January 25, 2017
Days to Decision	114 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.