LAURAIN DEWALD ANTERIOR FIXATION SYSTEM

Appliance, Fixation, Spinal Interlaminal

MEDTRONIC SOFAMOR DANEK

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Laurain Dewald Anterior Fixation System.

Pre-market Notification Details

• Device ID: K023797
• 510k Number: K023797
• Device Name: LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Contact: Richard W Treharne
• Correspondent: Richard W Treharne; MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-11-14
• Decision Date: 2002-12-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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