EVOL® -SI Joint Fusion System

Sacroiliac Joint Fixation

Cutting Edge Spine, LLC

The following data is part of a premarket notification filed by Cutting Edge Spine, Llc with the FDA for Evol® -si Joint Fusion System.

Pre-market Notification Details

• Device ID: K190025
• 510k Number: K190025
• Device Name: EVOL® -SI Joint Fusion System
• Classification: Sacroiliac Joint Fixation
• Applicant: Cutting Edge Spine, LLC 101 Waxhaw Professional Park, Suite A Waxhaw, NC 28173
• Contact: Kyle Kuntz
• Correspondent: Kyle Kuntz; Cutting Edge Spine, LLC 101 Waxhaw Professional Park Drive, Suite A Waxhaw, NC 28173
• Product Code: OUR
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-07
• Decision Date: 2019-08-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841193112022	K190025	000
00841193124971	K190025	000
00841193125107	K190025	000
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00841193124964	K190025	000
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00841193124902	K190025	000
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00841193122816	K190025	000
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00841193122991	K190025	000