Cleared Traditional

Reform Pedicle Screw System

K151422 · Precision Spine, Inc. · Orthopedic

Aug 2015

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K151422 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 August 21, 2015, 85 days after receiving the submission on May 28, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K151422 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2015
Decision Date	August 21, 2015
Days to Decision	85 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.