SurGenTec, LLC - FDA 510(k) Cleared Devices

Cleared Oct 14, 2026

Vantage Lumbar Decompression Kit

K263208 · HRX

Orthopedic · 30d

Cleared Aug 26, 2026

GraftGun Universal Graft Delivery System (GDS®)

K262581 · FMF

Orthopedic · 30d

Cleared Aug 24, 2026

TiLink-L™ SI Joint Fusion System

K261381 · OUR

Orthopedic · 119d

Cleared Jul 24, 2026

Ion-L Navigated Instruments

K262121 · OLO

Orthopedic · 31d

Cleared Jun 11, 2026

Ion-L

K261209 · MRW

Orthopedic · 59d

Cleared May 22, 2026

Ion-C Navigation Instruments

K260329 · OLO

Orthopedic · 112d

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