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Kyocera Medical Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242928Tesera-k SC SystemApril 10, 2025
K242045Initia T3 Acetabular Hemispherical Shell SystemApril 10, 2025
K242771Tesera-k PL System and Tesera-k XL SystemMarch 20, 2025
K243295Initia Knee SystemJanuary 13, 2025
K243015Skyway Anterior Cervical Plate SystemNovember 5, 2024
K232114TRIBRID® Unicompartmental Knee SystemApril 4, 2024
K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemApril 21, 2023
K223105Tesera-K SC SystemDecember 22, 2022
K212980Tesera-k ALIF SystemJanuary 7, 2022
K212070KMTI S141 Lumbar Interbody Fusion SystemAugust 30, 2021
K203472KMTI Hip Replacement SystemApril 2, 2021
K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous AceJuly 16, 2020
K200709Kyocera Bipolar Hip SystemApril 17, 2020
K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemMarch 11, 2020
K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemFebruary 4, 2020