Medical Device Manufacturer · US , Florence , SC

Degen Medical - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2015
16
Total
16
Cleared
0
Denied

FDA 510(k) cleared devices by Degen Medical Orthopedic

16 devices
1-16 of 16
Cleared Dec 08, 2025
DeGen Medical Patient Specific Implant (PSI) System
K251829 · OVD
Orthopedic · 178d
Cleared Oct 10, 2025
DeGen Medical Latitude-C AM Cervical Interbody Fusion System
K252737 · ODP
Orthopedic · 43d
Cleared Apr 04, 2025
DeGen Medical Patient Specific Implant (PSI) System
K250667 · MAX
Orthopedic · 30d
Cleared Oct 29, 2024
DeGen Medical Patient Specific Implant (PSI) System
K241077 · OVD
Orthopedic · 193d
Cleared Jun 16, 2023
Solar Lumbar Interbody Fusion System
K231199 · MAX
Orthopedic · 50d
Cleared Mar 17, 2023
DeGen Impulse AM™ System
K223418 · MAX
Orthopedic · 127d
Cleared Feb 09, 2022
DeGen Navigated Instrumentation
K213918 · OLO
Orthopedic · 56d
Cleared Jan 07, 2022
Cyclops™ Anterior Cervical Plate System
K213901 · KWQ
Orthopedic · 24d
Cleared Aug 30, 2021
Impulse AM Interbody Fusion System
K210090 · MAX
Orthopedic · 229d
Cleared Apr 02, 2021
DeGen Navigated Instrumentation
K203816 · OLO
Orthopedic · 94d
Cleared Dec 22, 2020
Impulse Interbody Fusion System
K201287 · MAX
Orthopedic · 222d
Cleared Jan 29, 2018
DeGen Medical E3 MIS Pedicle Screw System
K173814 · NKB
Orthopedic · 45d
Cleared Jun 28, 2016
F1 MPS Modular Pedicle Screw System
K160926 · NKB
Orthopedic · 85d
Cleared Dec 15, 2015
Latitude-C Cervical Interbody Spacer System
K151496 · ODP
Orthopedic · 195d
Cleared Jul 28, 2015
Hyper-C Anterior Cervical Plate System
K150759 · KWQ
Orthopedic · 127d
Cleared Mar 20, 2015
F1-Modular Pedicle Screw System
K142531 · NKB
Orthopedic · 192d
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