Medical Device Manufacturer · US , Round Rock , TX

Osseus Fusion Systems, LLC - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2013

Recent clearances: Blue Topaz Sacroiliac Screw System, Aries® Lumbar Interbodies

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Osseus Fusion Systems, LLC Orthopedic ✕

5 devices

1-5 of 5

Cleared Mar 01, 2022

Blue Topaz Sacroiliac Screw System

Orthopedic · 109d

Cleared Aug 15, 2018

Aries® Lumbar Interbodies

Orthopedic · 86d

Cleared Jul 03, 2017

Gemini-C Hybrid Cervical Interbody System

Orthopedic · 104d

Cleared Apr 26, 2016

White Pearl Preferred Angle Anterior Cervical Plate

Orthopedic · 61d

Cleared Aug 08, 2013

OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM

Orthopedic · 50d