Anterior Cervical Plate System

Appliance, Fixation, Spinal Intervertebral Body

Evolution Spine, LLC

The following data is part of a premarket notification filed by Evolution Spine, Llc with the FDA for Anterior Cervical Plate System.

Pre-market Notification Details

• Device ID: K173375
• 510k Number: K173375
• Device Name: Anterior Cervical Plate System
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: Evolution Spine, LLC 2300 N. Haskell Dallas, TX 75204
• Contact: Douglas Davis
• Correspondent: Douglas Davis; Evolution Spine, LLC 2300 N. Haskell Dallas, TX 75204
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-27
• Decision Date: 2017-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00195860009819	K173375	000
00195860009987	K173375	000
00195860009994	K173375	000
00195860010006	K173375	000
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00195860010273	K173375	000
00195860010440	K173375	000