Cleared Traditional

TSRH(R) SPINAL SYSTEM

K101772 · Medtronic Sofamor Danek · Orthopedic

Sep 2010

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K101772 is an FDA 510(k) clearance for the TSRH(R) 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 September 30, 2010, 98 days after receiving the submission on June 24, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K101772 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2010
Decision Date	September 30, 2010
Days to Decision	98 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.