Osseus Fusion Systems is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Osseus Fusion Systems - FDA 510(k) Cleared Devices
Recent clearances: Pisces™-SA STANDALONE ALIF Interbody System, Black Diamond™ POCT Spinal System, PISCES-SA Standalone ALIF Interbody System
5
Total
5
Cleared
0
Denied
Osseus Fusion Systems has 5 FDA 510(k) cleared medical devices. Based in Dallas, US.
Last cleared in 2023. Active since 2019. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Osseus Fusion Systems Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Jalex Medical, LLC and The OrthoMedix Group, Inc..
FDA 510(k) Regulatory Record - Osseus Fusion Systems
5 devices
Cleared
Feb 10, 2023
Pisces™-SA STANDALONE ALIF Interbody System
Orthopedic
93d
Cleared
Nov 03, 2022
Black Diamond™ POCT Spinal System
Orthopedic
108d
Cleared
May 06, 2022
PISCES-SA Standalone ALIF Interbody System
Orthopedic
141d
Cleared
Jan 17, 2020
Black Diamond Navigation Instruments
Orthopedic
128d
Cleared
Oct 29, 2019
Black Diamond Pedicle Screw System
Orthopedic
84d