Cleared Traditional

SYNTHES MATRIX SYSTEM

K100634 · Synthes (Usa) · Orthopedic

Jul 2010

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K100634 is an FDA 510(k) clearance for the SYNTHES MATRIX SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 1, 2010, 118 days after receiving the submission on March 5, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K100634 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2010
Decision Date	July 01, 2010
Days to Decision	118 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.