SurGenTec, LLC - FDA 510(k) Cleared Devices
Recent clearances: GraftGun Universal Graft Delivery System (GDS®), TiLink-L™ SI Joint Fusion System, Ion-L Navigated Instruments
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - SurGenTec, LLC Orthopedic ✕
23 devices
Cleared
Aug 26, 2026
GraftGun Universal Graft Delivery System (GDS®)
Orthopedic
30d
Cleared
Aug 24, 2026
TiLink-L™ SI Joint Fusion System
Orthopedic
119d
Cleared
Jul 24, 2026
Ion-L Navigated Instruments
Orthopedic
31d
Cleared
Jun 11, 2026
Ion-L
Orthopedic
59d
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