Cleared Special

TSRH SPINAL SYSTEM

K103049 · Medtronic Sofamor Danek · Orthopedic

Dec 2010

Decision

69d

Days

Class 2

Risk

About This 510(k) Submission

K103049 is an FDA 510(k) clearance for the TSRH SPINAL SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on December 23, 2010, 69 days after receiving the submission on October 15, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K103049 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2010
Decision Date	December 23, 2010
Days to Decision	69 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.