Cleared Traditional

NEO Pedicle Screw System?

K171582 · Neo Medical SA · Orthopedic

Sep 2017

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K171582 is an FDA 510(k) clearance for the NEO Pedicle Screw System?, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Neo Medical SA (Villette (Lavaux), CH). The FDA issued a Cleared decision on September 12, 2017, 104 days after receiving the submission on May 31, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K171582 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2017
Decision Date	September 12, 2017
Days to Decision	104 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.