Medical Device Manufacturer · US , Redlands , CA

Kyocera Medical Technologies, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2020

Recent clearances: Initia T3 Acetabular Hemispherical Shell System, Tesera-k SC System, Tesera-k PL System and Tesera-k XL System

16
Total
16
Cleared
0
Denied

Kyocera Medical Technologies, Inc. has 16 FDA 510(k) cleared orthopedic devices. Based in Redlands, US.

Latest FDA clearance: Jul 2026. Active since 2020.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Empirical Technologies, MEDIcept, Inc. and Empirical Testing Corp.

FDA 510(k) Regulatory Record - Kyocera Medical Technologies, Inc.

16 devices
1-16 of 16
Cleared Jul 15, 2026
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System
K261353 · OVD
Orthopedic · 82d
Cleared Apr 10, 2025
Initia T3 Acetabular Hemispherical Shell System
K242045 · LPH
Orthopedic · 272d
Cleared Apr 10, 2025
Tesera-k SC System
K242928 · OVE
Orthopedic · 198d
Cleared Mar 20, 2025
Tesera-k PL System and Tesera-k XL System
K242771 · MAX
Orthopedic · 188d
Cleared Jan 13, 2025
Initia Knee System
K243295 · JWH
Orthopedic · 87d
Cleared Nov 05, 2024
Skyway Anterior Cervical Plate System
K243015 · KWQ
Orthopedic · 39d
Cleared Apr 04, 2024
TRIBRID® Unicompartmental Knee System
K232114 · HSX
Orthopedic · 265d
Cleared Apr 21, 2023
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
K230808 · OVD
Orthopedic · 29d
Cleared Dec 22, 2022
Tesera-K SC System
K223105 · OVE
Orthopedic · 83d
Cleared Jan 07, 2022
Tesera-k ALIF System
K212980 · OVD
Orthopedic · 112d
Cleared Aug 30, 2021
KMTI S141 Lumbar Interbody Fusion System
K212070 · MAX
Orthopedic · 59d
Cleared Apr 02, 2021
KMTI Hip Replacement System
K203472 · OQG
Orthopedic · 128d
Cleared Jul 16, 2020
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular...
K201660 · OQG
Orthopedic · 28d
Cleared Apr 17, 2020
Kyocera Bipolar Hip System
K200709 · KWY
Orthopedic · 30d
Cleared Mar 11, 2020
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous...
K200328 · OQG
Orthopedic · 30d
Cleared Feb 04, 2020
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
K193320 · OVD
Orthopedic · 64d
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