Degen Medical - FDA 510(k) Cleared Devices
Recent clearances: DeGen Medical Patient Specific Implant (PSI) System, DeGen Medical Latitude-C AM Cervical Interbody Fusion System, DeGen Medical Patient Specific Implant (PSI) System
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Degen Medical Orthopedic ✕
16 devices
Cleared
Dec 08, 2025
DeGen Medical Patient Specific Implant (PSI) System
Orthopedic
178d
Cleared
Oct 10, 2025
DeGen Medical Latitude-C AM Cervical Interbody Fusion System
Orthopedic
43d
Cleared
Apr 04, 2025
DeGen Medical Patient Specific Implant (PSI) System
Orthopedic
30d
Cleared
Oct 29, 2024
DeGen Medical Patient Specific Implant (PSI) System
Orthopedic
193d
Cleared
Jun 16, 2023
Solar Lumbar Interbody Fusion System
Orthopedic
50d
Cleared
Mar 17, 2023
DeGen Impulse AM™ System
Orthopedic
127d
Cleared
Feb 09, 2022
DeGen Navigated Instrumentation
Orthopedic
56d
Cleared
Jan 07, 2022
Cyclops™ Anterior Cervical Plate System
Orthopedic
24d
Cleared
Aug 30, 2021
Impulse AM Interbody Fusion System
Orthopedic
229d
Cleared
Apr 02, 2021
DeGen Navigated Instrumentation
Orthopedic
94d
Cleared
Dec 22, 2020
Impulse Interbody Fusion System
Orthopedic
222d
Cleared
Jan 29, 2018
DeGen Medical E3 MIS Pedicle Screw System
Orthopedic
45d