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

Degen Medical has 16 FDA 510(k) cleared orthopedic devices. Based in Florence, US.

Latest FDA clearance: Dec 2025. Active since 2015.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Secure BioMed Evaluations and Secure Biomed Evalutations.

FDA 510(k) Regulatory Record - Degen Medical
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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