THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS

Appliance, Fixation, Spinal Intervertebral Body

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Thoracolumbar, Lumbar And Sacral Plates And 6.0 And 7.0 Mm Bone Screws.

Pre-market Notification Details

• Device ID: K081380
• 510k Number: K081380
• Device Name: THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Contact: Richard W Woods
• Correspondent: Richard W Woods; K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-05-16
• Decision Date: 2008-11-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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