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DEGEN MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106633723010663372DEGEN MEDICAL1N2027-01-011321C N Cashua Dr Florence SC US 29501

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1770681879918371K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemODP2025-10-10
1770681450259220K251829DeGen Medical Patient Specific Implant (PSI) SystemOVD2025-12-08
1770681740452389K250667DeGen Medical Patient Specific Implant (PSI) SystemMAX2025-04-04
1770681544285340K241077DeGen Medical Patient Specific Implant (PSI) SystemOVD2024-10-29
1770681326795422K240326Solar™ Lumbar Interbody Fusion SystemMAX2024-07-29
1770681165268513K231199Solar Lumbar Interbody Fusion SystemMAX2023-06-16
1770681077330677K213918DeGen Navigated InstrumentationOLO2022-02-09
1770681166841421K213901Cyclops™ Anterior Cervical Plate SystemKWQ2022-01-07
1770681748032986K210090Impulse AM Interbody Fusion SystemMAX2021-08-30
1770681987923914K203816DeGen Navigated InstrumentationOLO2021-04-02
1770681967623582K201287Impulse Interbody Fusion SystemMAX2020-12-22
1770681997467449K191786Cyclops™ Anterior Cervical Plate SystemKWQ2019-08-30
1770682044264623K173814DeGen Medical E3 MIS Pedicle Screw SystemNKB2018-01-29
1770681672713287K151496Latitude-C Cervical Interbody Spacer SystemODP2015-12-15
1770681709014966K150759Hyper-C Anterior Cervical Plate SystemKWQ2015-07-28
1770682057579634K142531F1-Modular Pedicle Screw SystemNKB2015-03-20
1770681424670216
1770681599945448
1770682008480209

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX52025-04-04
KWQ32022-01-07
OVD22025-12-08
ODP22025-10-10
OLO22022-02-09
NKB22018-01-29

PMN#