T-FIX® 3DSI 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 T-fix® 3dsi Joint Fusion System.

Pre-market Notification Details

• Device ID: K214123
• 510k Number: K214123
• Device Name: T-FIX® 3DSI Joint Fusion System
• Classification: Sacroiliac Joint Fixation
• Applicant: Cutting Edge Spine, LLC 6012 Waxhaw Hwy Mineral Springs, NC 28108
• Contact: Kyle Kuntz
• Correspondent: Kyle Kuntz; Cutting Edge Spine, LLC 6012 Waxhaw Hwy Mineral Springs, NC 28108
• Product Code: OUR
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-30
• Decision Date: 2022-06-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841193125855	K214123	000
00841193125473	K214123	000
00841193125466	K214123	000
00841193125459	K214123	000
00841193125442	K214123	000
00841193125435	K214123	000
00841193125428	K214123	000
00841193125411	K214123	000
00841193125404	K214123	000
00841193125398	K214123	000
00841193125381	K214123	000
00841193125374	K214123	000
00841193125367	K214123	000
00841193125350	K214123	000
00841193125343	K214123	000
00841193125336	K214123	000
00841193125329	K214123	000
00841193125312	K214123	000
00841193125664	K214123	000
00841193125671	K214123	000
00841193125848	K214123	000
00841193125831	K214123	000
00841193125824	K214123	000
00841193125817	K214123	000
00841193125800	K214123	000
00841193125794	K214123	000
00841193125787	K214123	000
00841193125770	K214123	000
00841193125763	K214123	000
00841193125756	K214123	000
00841193125749	K214123	000
00841193125732	K214123	000
00841193125725	K214123	000
00841193125718	K214123	000
00841193125701	K214123	000
00841193125695	K214123	000
00841193125688	K214123	000
00841193125305	K214123	000