510(k) K241077

DeGen Medical Patient Specific Implant (PSI) System by Degen Medical — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 29, 2024
Date Received: April 19, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Degen Medical

K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
K252737 — DeGen Medical Latitude-C AM Cervical Interbody Fusion System (October 10, 2025)
K250667 — DeGen Medical Patient Specific Implant (PSI) System (April 4, 2025)
K240326 — Solar Lumbar Interbody Fusion System (July 29, 2024)
K231199 — Solar Lumbar Interbody Fusion System (June 16, 2023)
K223418 — DeGen Impulse AM System (March 17, 2023)
K213918 — DeGen Navigated Instrumentation (February 9, 2022)
K213901 — Cyclops Anterior Cervical Plate System (January 7, 2022)
K210090 — Impulse AM Interbody Fusion System (August 30, 2021)
K203816 — DeGen Navigated Instrumentation (April 2, 2021)

Other clearances for product code OVD

K253559 — Ventana A Anterior Lumbar Interbody System (February 25, 2026)
K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb (September 3, 2025)
K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)