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Data / Medical devices / United States / Degen Medical

Degen Medical: FDA-registered device maker in Florence, SC, United States, 16 510(k) clearances

Degen Medical is registered with the FDA (registration 3010663372) in Florence, SC, United States. It lists 14 device types. The FDA files 16 510(k) clearances under its listings, the newest dated December 8, 2025. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Degen Medical
FDA registration number
3010663372
Address
1321C N Cashua Dr, Florence, SC, United States, 29501
Owner or operator
DeGen Medical (10048016)
Roles
Complaint file establishment, Specification developer
First device listed
November 25, 2014
Registered through
2027
Brand names listed
Augmenta, Connect-L, Cyclops, DeGen Navigated Instrumentation, E3, F1 MPS, Hyper-C, Impulse AM Interbody Fusion System and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Complaint file establishment, Specification developeraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Specification developeraccessdata.fda.gov
ImpactorHWA1Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Complaint file establishment, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Complaint file establishment, Specification developeraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Complaint file establishment, Specification developeraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Complaint file establishment, Specification developeraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Complaint file establishment, Specification developeraccessdata.fda.gov
Spinal Channeling Instrument, VertebroplastyOCJ1Complaint file establishment, Specification developeraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 8, 2025K251829DeGen Medical Patient Specific Implant (PSI) SystemOVDSubstantially EquivalentDegen Medicalaccessdata.fda.gov
October 10, 2025K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemODPSubstantially EquivalentDegen Medicalaccessdata.fda.gov
April 4, 2025K250667DeGen Medical Patient Specific Implant (PSI) SystemMAXSubstantially EquivalentDegen Medicalaccessdata.fda.gov
October 29, 2024K241077DeGen Medical Patient Specific Implant (PSI) SystemOVDSubstantially EquivalentDegen Medicalaccessdata.fda.gov
July 29, 2024K240326Solar™ Lumbar Interbody Fusion SystemMAXSubstantially EquivalentDegen Medical, Inc.accessdata.fda.gov
June 16, 2023K231199Solar Lumbar Interbody Fusion SystemMAXSubstantially EquivalentDegen Medicalaccessdata.fda.gov
February 9, 2022K213918DeGen Navigated InstrumentationOLOSubstantially EquivalentDegen Medicalaccessdata.fda.gov
January 7, 2022K213901Cyclops™ Anterior Cervical Plate SystemKWQSubstantially EquivalentDegen Medicalaccessdata.fda.gov
August 30, 2021K210090Impulse AM Interbody Fusion SystemMAXSubstantially EquivalentDegen Medicalaccessdata.fda.gov
April 2, 2021K203816DeGen Navigated InstrumentationOLOSubstantially EquivalentDegen Medicalaccessdata.fda.gov
December 22, 2020K201287Impulse Interbody Fusion SystemMAXSubstantially EquivalentDegen Medicalaccessdata.fda.gov
August 30, 2019K191786Cyclops™ Anterior Cervical Plate SystemKWQSubstantially EquivalentDegen Medical, Inc.accessdata.fda.gov
January 29, 2018K173814DeGen Medical E3 MIS Pedicle Screw SystemNKBSubstantially EquivalentDegen Medicalaccessdata.fda.gov
December 15, 2015K151496Latitude-C Cervical Interbody Spacer SystemODPSubstantially EquivalentDegen Medicalaccessdata.fda.gov
July 28, 2015K150759Hyper-C Anterior Cervical Plate SystemKWQSubstantially EquivalentDegen Medicalaccessdata.fda.gov
March 20, 2015K142531F1-Modular Pedicle Screw SystemNKBSubstantially EquivalentDegen Medicalaccessdata.fda.gov

Compare with other makers

Updated December 8, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.