Cleared Special

Reform Pedicle Screw System

K150856 · Precision Spine, Inc. · Orthopedic

Jul 2015

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K150856 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. (Pear, US). The FDA issued a Cleared decision on July 7, 2015, 98 days after receiving the submission on March 31, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K150856 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2015
Decision Date	July 07, 2015
Days to Decision	98 days
Submission Type	Special
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.