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510(k) K230808

PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System by Kyocera Medical Technologies, Inc. — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2023
Date Received
March 23, 2023
Clearance Type
Special
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.

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  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K223105 — Tesera-K SC System (December 22, 2022)
  • K212980 — Tesera-k ALIF System (January 7, 2022)
  • K212070 — KMTI S141 Lumbar Interbody Fusion System (August 30, 2021)
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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)