EVEREST SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

K2M, INC.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Everest Spinal System.

Pre-market Notification Details

• Device ID: K120656
• 510k Number: K120656
• Device Name: EVEREST SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: K2M, INC. 751 MILLER DRIVE SE Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M, INC. 751 MILLER DRIVE SE Leesburg, VA 20175
• Product Code: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-05
• Decision Date: 2012-04-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888857008960	K120656	000
10888857008946	K120656	000
10888857008922	K120656	000