Cleared Traditional

Reform Pedicle Screw System

K143248 · Precision Spine, Inc. · Orthopedic

Dec 2014

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K143248 is an FDA 510(k) clearance for the Reform Pedicle Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Precision Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on December 19, 2014, 37 days after receiving the submission on November 12, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K143248 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2014
Decision Date	December 19, 2014
Days to Decision	37 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.