PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

MEDTRONIC SOFAMOR DANEK USA, INC.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Pyramid +4 Anterior Lumbar Spine Plate System.

Pre-market Notification Details

• Device ID: K071416
• 510k Number: K071416
• Device Name: PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Christine Scifert
• Correspondent: Christine Scifert; MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-05-21
• Decision Date: 2007-11-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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