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510(k) K212980

Tesera-k ALIF System by Kyocera Medical Technologies, Inc. — Product Code OVD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
September 17, 2021
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 Kyocera Medical Technologies, Inc.

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  • K242771 — Tesera-k PL System and Tesera-k XL System (March 20, 2025)
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  • K243015 — Skyway Anterior Cervical Plate System (November 5, 2024)
  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K230808 — PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (April 21, 2023)
  • K223105 — Tesera-K SC System (December 22, 2022)
  • K212070 — KMTI S141 Lumbar Interbody Fusion System (August 30, 2021)
  • K203472 — KMTI Hip Replacement System (April 2, 2021)

Other clearances for product code OVD

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  • 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)