Kyocera Medical Technologies, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Kyocera Medical Technologies, Inc. - FDA 510(k) Cleared Devices
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
Cleared
Jul 15, 2026
Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System
Orthopedic
82d
Cleared
Apr 10, 2025
Initia T3 Acetabular Hemispherical Shell System
Orthopedic
272d
Cleared
Apr 10, 2025
Tesera-k SC System
Orthopedic
198d
Cleared
Mar 20, 2025
Tesera-k PL System and Tesera-k XL System
Orthopedic
188d
Cleared
Jan 13, 2025
Initia Knee System
Orthopedic
87d
Cleared
Nov 05, 2024
Skyway Anterior Cervical Plate System
Orthopedic
39d
Cleared
Apr 04, 2024
TRIBRID® Unicompartmental Knee System
Orthopedic
265d
Cleared
Apr 21, 2023
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
Orthopedic
29d
Cleared
Dec 22, 2022
Tesera-K SC System
Orthopedic
83d
Cleared
Jan 07, 2022
Tesera-k ALIF System
Orthopedic
112d
Cleared
Aug 30, 2021
KMTI S141 Lumbar Interbody Fusion System
Orthopedic
59d
Cleared
Apr 02, 2021
KMTI Hip Replacement System
Orthopedic
128d