Kyocera Medical Technologies, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System, Initia T3 Acetabular Hemispherical Shell System, Tesera-k SC 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