MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Modification To Pyrenees Cervical Plate System.

Pre-market Notification Details

• Device ID: K063544
• 510k Number: K063544
• Device Name: MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Contact: Rich Woods
• Correspondent: Rich Woods; K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-24
• Decision Date: 2007-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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