Cutting Edge Spine, LLC - FDA 510(k) Cleared Devices
Recent clearances: EVOL® ha – Hyper C Cervical Interbody Fusion System, T-FIX™ 3DSI Joint Fusion System, T-FIX® 3DSI Joint Fusion System
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cutting Edge Spine, LLC Orthopedic ✕
11 devices
Cleared
Mar 12, 2025
EVOL® ha – Hyper C Cervical Interbody Fusion System
Orthopedic
12d
Cleared
Apr 05, 2023
T-FIX™ 3DSI Joint Fusion System
Orthopedic
23d
Cleared
Jun 24, 2022
T-FIX® 3DSI Joint Fusion System
Orthopedic
176d
Cleared
May 13, 2020
EVOL Spinal Interbody System
Orthopedic
28d
Cleared
Apr 02, 2020
EVOS Lumbar Interbody System
Orthopedic
30d
Cleared
Jan 06, 2020
EVOL ha - D Lateral Interbody Fusion System
Orthopedic
117d
Cleared
Aug 12, 2019
EVOL® -SI Joint Fusion System
Orthopedic
217d
Cleared
Jun 25, 2018
EVOL® ha-C Cervical Interbody Fusion System
Orthopedic
102d
Cleared
May 04, 2018
EVOL Spinal Interbody System, EVOS Lumbar Interbody System
Orthopedic
29d
Cleared
Jul 13, 2015
EVOS Lumbar Interbody System
Orthopedic
154d
Cleared
Apr 28, 2011
CUTTING EDGE SPINE INTERBODY FUSION DEVICE
Orthopedic
205d