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Kyocera Medical Technologies, Inc.

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories9
Latest FDA decision2026-07-15
TypeNumberDevice NameCodeDateActions
510(k) K261353 Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemOVD2026-07-15 View
510(k) K242928 Tesera-k SC SystemOVE2025-04-10 View
510(k) K242045 Initia T3 Acetabular Hemispherical Shell SystemLPH2025-04-10 View
510(k) K242771 Tesera-k PL System and Tesera-k XL SystemMAX2025-03-20 View
510(k) K243295 Initia Knee SystemJWH2025-01-13 View
510(k) K243015 Skyway Anterior Cervical Plate SystemKWQ2024-11-05 View
510(k) K232114 TRIBRID® Unicompartmental Knee SystemHSX2024-04-04 View
510(k) K230808 PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD2023-04-21 View
510(k) K223105 Tesera-K SC SystemOVE2022-12-22 View
510(k) K212980 Tesera-k ALIF SystemOVD2022-01-07 View
510(k) K212070 KMTI S141 Lumbar Interbody Fusion SystemMAX2021-08-30 View
510(k) K203472 KMTI Hip Replacement SystemOQG2021-04-02 View
510(k) K201660 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemOQG2020-07-16 View
510(k) K200709 Kyocera Bipolar Hip SystemKWY2020-04-17 View
510(k) K200328 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemOQG2020-03-11 View
510(k) K193320 KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD2020-02-04 View
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