Medical Device Manufacturer · US , Parsippany , NJ

Onkos Surgical - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2020

Recent clearances: My3D® Personalized Pelvic Reconstruction, ELEOS Limb Salvage System, ELEOS Limb Salvage System with BioGrip

6

Total

5

Cleared

1

Denied

FDA 510(k) Regulatory Record - Onkos Surgical Orthopedic ✕

6 devices

1-6 of 6

Not Cleared Apr 05, 2024

ELEOSx™ Limb Salvage System

DEN210058 · QZZ

Orthopedic · 827d

Cleared Jul 06, 2022

My3D® Personalized Pelvic Reconstruction

Orthopedic · 306d

Cleared Jul 28, 2021

ELEOS Limb Salvage System

Orthopedic · 57d

Cleared Jun 09, 2021

ELEOS Limb Salvage System with BioGrip

Orthopedic · 162d

Cleared Feb 05, 2021

ELEOS™ Limb Salvage System

Orthopedic · 59d

Cleared Dec 11, 2020

ELEOS Limb Salvage System featuring BIOGRIP

Orthopedic · 59d