Osseus Fusion Systems, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Osseus Fusion Systems, LLC - FDA 510(k) Cleared Devices
Recent clearances: Blue Topaz Sacroiliac Screw System, Aries® Lumbar Interbodies
5
Total
5
Cleared
0
Denied
Osseus Fusion Systems, LLC has 5 FDA 510(k) cleared medical devices. Based in Round Rock, US.
Last cleared in 2022. Active since 2013. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Osseus Fusion Systems, LLC Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by The OrthoMedix Group, Inc. and Empirical Testing Corp.
FDA 510(k) Regulatory Record - Osseus Fusion Systems, LLC
5 devices
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