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510(k) K191489

Genesys Spine 3DP Cervical Interbody System by Genesys Spine — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2020
Date Received
June 4, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by Genesys Spine

  • K252322 — SIros-X System (October 22, 2025)
  • K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System (February 7, 2025)
  • K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation (March 29, 2024)
  • K233594 — Genesys Spine 3DP AIS-C II Cervical Interbody System (December 13, 2023)
  • K220096 — Genesys Spine 3DP Lumbar Interbody System (March 9, 2022)
  • K182987 — Genesys Spine 3DP Lumbar Interbody System (December 12, 2019)
  • K192678 — Genesys Spine Binary® Lumbar Plate System (October 24, 2019)
  • K191748 — Genesys Spine Sacroiliac Joint Fusion System (September 26, 2019)
  • K192076 — Binary® Anterior Cervical Plate System (August 29, 2019)
  • K181295 — Genesys Spine AIS-C Cervical Stand-Alone System (August 29, 2018)

Other clearances for product code OVE

  • K260038 — E3D™-C Interbody System (February 4, 2026)
  • K253876 — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (December 22, 2025)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)
  • K250540 — SABER-C System (August 8, 2025)
  • K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
  • K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
  • K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
  • K242928 — Tesera-k SC System (April 10, 2025)
  • K243188 — CYLOX® ST (February 11, 2025)