SurGenTec, LLC - FDA 510(k) Cleared Devices

Cleared Mar 20, 2026

TiLink-L Navigation Instruments

K253604 · OLO

Orthopedic · 122d

Cleared Jan 16, 2026

Ion-C

K251714 · MRW

Orthopedic · 227d

Cleared Jul 02, 2025

OsteoFlo HydroFiber

K251720 · MQV

Orthopedic · 28d

Cleared May 28, 2025

OsteoFlo HydroFiber

K243949 · MQV

Orthopedic · 156d

Cleared Feb 05, 2025

GraftGun Universal Graft Delivery System (GDS)

K243580 · FMF

Orthopedic · 78d

Cleared Dec 27, 2024

TiLink-P SI Joint Fusion System

K243835 · OUR

Orthopedic · 14d

Cleared Dec 23, 2024

OsteoFlo HydroFiber

K242797 · MQV

Orthopedic · 98d

Cleared Dec 04, 2024

Ion 3D

K243265 · MRW

Orthopedic · 50d

Cleared Nov 21, 2024

TiLink-P Joint Fusion System

K242414 · OUR

Orthopedic · 99d

Cleared Aug 21, 2024

TiLink-P SI Joint Fusion System

K242141 · OUR

Orthopedic · 30d

Cleared Jun 17, 2024

Ion 3D

K241416 · MRW

Orthopedic · 31d

Cleared Apr 11, 2024

TiLink-P SI Joint Fusion System

K240720 · OUR

Orthopedic · 27d