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
FDA 510(k) Regulatory Record - Kyocera Medical Technologies, Inc. Orthopedic ✕
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
Cleared
Jul 16, 2020
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular...
Orthopedic
28d
Cleared
Apr 17, 2020
Kyocera Bipolar Hip System
Orthopedic
30d
Cleared
Mar 11, 2020
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous...
Orthopedic
30d
Cleared
Feb 04, 2020
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
Orthopedic
64d