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510(k) K250667

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

K250667 is an FDA 510(k) premarket notification submitted by Degen Medical for the device "DeGen Medical Patient Specific Implant (PSI) System". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Degen Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
March 5, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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)
  • K241077 — DeGen Medical Patient Specific Implant (PSI) System (October 29, 2024)
  • 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 MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources