Cleared Traditional

PASS XS Spinal System

K160640 · Medicrea International SA · Orthopedic

Sep 2016

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K160640 is an FDA 510(k) clearance for the PASS XS 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 September 23, 2016, 200 days after receiving the submission on March 7, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K160640 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2016
Decision Date	September 23, 2016
Days to Decision	200 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.