Osseus Fusion Systems - FDA 510(k) Cleared Devices
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.
510(k) submissions have been managed by Jalex Medical, LLC as regulatory consultant.
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