Cleared Traditional

Reform? Midline Cortical Screw System

K173130 · Precision Spine, Inc. · Orthopedic

Dec 2017

Decision

81d

Days

Class 2

Risk

About This 510(k) Submission

K173130 is an FDA 510(k) clearance for the Reform? Midline Cortical Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on December 19, 2017, 81 days after receiving the submission on September 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K173130 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	December 19, 2017
Days to Decision	81 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.