SurGenTec, LLC - FDA 510(k) Cleared Devices
Recent clearances: Ion-C Navigation Instruments, TiLink-L Navigation Instruments, Ion-C
24
Total
24
Cleared
0
Denied
FDA 510(k) Regulatory Record - SurGenTec, LLC Orthopedic ✕
19 devices
Cleared
May 22, 2026
Ion-C Navigation Instruments
Orthopedic
112d
Cleared
Mar 20, 2026
TiLink-L Navigation Instruments
Orthopedic
122d
Cleared
Jan 16, 2026
Ion-C
Orthopedic
227d
Cleared
Jul 02, 2025
OsteoFlo HydroFiber
Orthopedic
28d
Cleared
May 28, 2025
OsteoFlo HydroFiber
Orthopedic
156d
Cleared
Feb 05, 2025
GraftGun Universal Graft Delivery System (GDS)
Orthopedic
78d
Cleared
Dec 27, 2024
TiLink-P SI Joint Fusion System
Orthopedic
14d
Cleared
Dec 23, 2024
OsteoFlo HydroFiber
Orthopedic
98d
Cleared
Dec 04, 2024
Ion 3D
Orthopedic
50d
Cleared
Nov 21, 2024
TiLink-P Joint Fusion System
Orthopedic
99d
Cleared
Aug 21, 2024
TiLink-P SI Joint Fusion System
Orthopedic
30d
Cleared
Jun 17, 2024
Ion 3D
Orthopedic
31d
Cleared
Apr 11, 2024
TiLink-P SI Joint Fusion System
Orthopedic
27d
Cleared
Feb 08, 2024
Ion 3D
Orthopedic
28d
Cleared
Oct 02, 2023
OsteoFlo® HydroPutty™
Orthopedic
111d
Cleared
Sep 25, 2023
TiLink-P SI Joint Fusion System
Orthopedic
180d
Cleared
Jun 07, 2023
TiLink-L SI Joint Fusion System
Orthopedic
106d
Cleared
Feb 25, 2022
Ion Facet Screw System
Orthopedic
254d
Cleared
Aug 14, 2020
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
Orthopedic
214d