Medical Device Manufacturer · US , Florence , SC

Degen Medical

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

Degen Medical — FDA 510(k) Submissions

Degen Medical has submitted 16 FDA 510(k) premarket notifications since 2015, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System, Orthopedic Stereotaxic Instrument, Intervertebral Fusion Device With Integrated Fixation, Lumbar, Appliance, Fixation, Spinal Intervertebral Body . Use the specialty filter in the sidebar to narrow results.

16 devices
1–12 of 16
DeGen Medical Patient Specific Implant (PSI) System
K251829 · OVD Intervertebral Fusion... · Orthopedic
Dec 2025 178d
DeGen Medical Latitude-C AM Cervical Interbody Fusion System
K252737 · ODP Intervertebral Fusion... · Orthopedic
Oct 2025 43d
DeGen Medical Patient Specific Implant (PSI) System
K250667 · MAX Intervertebral Fusion... · Orthopedic
Apr 2025 30d
DeGen Medical Patient Specific Implant (PSI) System
K241077 · OVD Intervertebral Fusion... · Orthopedic
Oct 2024 193d
Solar Lumbar Interbody Fusion System
K231199 · MAX Intervertebral Fusion... · Orthopedic
Jun 2023 50d
DeGen Impulse AM? System
K223418 · MAX Intervertebral Fusion... · Orthopedic
Mar 2023 127d
DeGen Navigated Instrumentation
K213918 · OLO Orthopedic Stereotaxic... · Orthopedic
Feb 2022 56d
Cyclops? Anterior Cervical Plate System
K213901 · KWQ Appliance, Fixation,... · Orthopedic
Jan 2022 24d
Impulse AM Interbody Fusion System
K210090 · MAX Intervertebral Fusion... · Orthopedic
Aug 2021 229d
DeGen Navigated Instrumentation
K203816 · OLO Orthopedic Stereotaxic... · Orthopedic
Apr 2021 94d
Impulse Interbody Fusion System
K201287 · MAX Intervertebral Fusion... · Orthopedic
Dec 2020 222d
DeGen Medical E3 MIS Pedicle Screw System
K173814 · NKB Thoracolumbosacral... · Orthopedic
Jan 2018 45d
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