Chrysalis Intelligence · Sponsors · Degen Medical

Degen Medical

Florence, SC, US · 12 510(k) clearances

Total clearances
12
2020-12-22 → 2025-12-08
Last 12 months
2
Product codes
5
Most recent
2025-12-08
Name variants in FDA filings: Degen Medical / Degen Medical, Inc.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 6 2025-04-04
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Class II Orthopedic 2 2025-12-08
OLO Orthopedic Stereotaxic Instrument Class II Neurology 2 2022-02-09
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 1 2025-10-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Class II Orthopedic 1 2022-01-07
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2025-12-08 K251829 DeGen Medical Patient Specific Implant (PSI) System OVD Class II Orthopedic
2025-10-10 K252737 DeGen Medical Latitude-C AM Cervical Interbody Fusion System ODP Class II Orthopedic
2025-04-04 K250667 DeGen Medical Patient Specific Implant (PSI) System MAX Class II Orthopedic
2024-10-29 K241077 DeGen Medical Patient Specific Implant (PSI) System OVD Class II Orthopedic
2024-07-29 K240326 Solar™ Lumbar Interbody Fusion System MAX Class II Orthopedic
2023-06-16 K231199 Solar Lumbar Interbody Fusion System MAX Class II Orthopedic
2023-03-17 K223418 DeGen Impulse AM™ System MAX Class II Orthopedic
2022-02-09 K213918 DeGen Navigated Instrumentation OLO Class II Neurology
2022-01-07 K213901 Cyclops™ Anterior Cervical Plate System KWQ Class II Orthopedic
2021-08-30 K210090 Impulse AM Interbody Fusion System MAX Class II Orthopedic
2021-04-02 K203816 DeGen Navigated Instrumentation OLO Class II Neurology
2020-12-22 K201287 Impulse Interbody Fusion System MAX Class II Orthopedic