TSRH SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

MEDTRONIC SOFAMOR DANEK, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Tsrh Spinal System.

Pre-market Notification Details

• Device ID: K092676
• 510k Number: K092676
• Device Name: TSRH SPINAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Lila Joe
• Correspondent: Lila Joe; MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-09-01
• Decision Date: 2009-10-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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