Degen Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251829DeGen Medical Patient Specific Implant (PSI) SystemDecember 8, 2025
K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemOctober 10, 2025
K250667DeGen Medical Patient Specific Implant (PSI) SystemApril 4, 2025
K241077DeGen Medical Patient Specific Implant (PSI) SystemOctober 29, 2024
K240326Solar™ Lumbar Interbody Fusion SystemJuly 29, 2024
K231199Solar Lumbar Interbody Fusion SystemJune 16, 2023
K223418DeGen Impulse AM™ SystemMarch 17, 2023
K213918DeGen Navigated InstrumentationFebruary 9, 2022
K213901Cyclops™ Anterior Cervical Plate SystemJanuary 7, 2022
K210090Impulse AM Interbody Fusion SystemAugust 30, 2021
K203816DeGen Navigated InstrumentationApril 2, 2021
K201287Impulse Interbody Fusion SystemDecember 22, 2020
K191786Cyclops™ Anterior Cervical Plate SystemAugust 30, 2019
K173814DeGen Medical E3 MIS Pedicle Screw SystemJanuary 29, 2018
K160926F1 MPS Modular Pedicle Screw SystemJune 28, 2016
K151496Latitude-C Cervical Interbody Spacer SystemDecember 15, 2015
K150759Hyper-C Anterior Cervical Plate SystemJuly 28, 2015
K142531F1-Modular Pedicle Screw SystemMarch 20, 2015