RANGE/MESA/DENALI SPINAL SYSTEM

Thoracolumbosacral Pedicle Screw System

K2M, INC.

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

Pre-market Notification Details

• Device ID: K140765
• 510k Number: K140765
• Device Name: RANGE/MESA/DENALI SPINAL SYSTEM
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Contact: Nancy Giezen
• Correspondent: Nancy Giezen; K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-27
• Decision Date: 2014-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888857051867	K140765	000
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