Cleared Special

TSRH SPINAL SYSTEM

K110676 · Medtronic Sofamor Danek · Orthopedic

May 2011

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K110676 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 May 23, 2011, 74 days after receiving the submission on March 10, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K110676 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2011
Decision Date	May 23, 2011
Days to Decision	74 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.