510(k) K242928

Tesera-k SC System by Kyocera Medical Technologies, Inc. — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 10, 2025
Date Received: September 24, 2024
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 Kyocera Medical Technologies, Inc.

K242045 — Initia T3 Acetabular Hemispherical Shell System (April 10, 2025)
K242771 — Tesera-k PL System and Tesera-k XL System (March 20, 2025)
K243295 — Initia Knee System (January 13, 2025)
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)
K212980 — Tesera-k ALIF System (January 7, 2022)
K212070 — KMTI S141 Lumbar Interbody Fusion System (August 30, 2021)
K203472 — KMTI Hip Replacement System (April 2, 2021)

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)
K243188 — CYLOX® ST (February 11, 2025)
K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System (February 7, 2025)