Cleared Traditional

PASS LP Spinal System

K161627 · Medicrea International SA · Orthopedic

Jul 2016

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K161627 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 July 29, 2016, 46 days after receiving the submission on June 13, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K161627 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2016
Decision Date	July 29, 2016
Days to Decision	46 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.