Medical Device Manufacturer · US , Redlands , CA

Kyocera Medical Technologies, Inc.

15 submissions · 15 cleared · Since 2020
15
Total
15
Cleared
0
Denied

Kyocera Medical Technologies, Inc. — FDA 510(k) Submissions

Kyocera Medical Technologies, Inc. has submitted 15 FDA 510(k) premarket notifications since 2020, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intervertebral Fusion Device With Integrated Fixation, Lumbar, Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented, Intervertebral Fusion Device With Integrated Fixation, Cervical, Intervertebral Fusion Device With Bone Graft, Lumbar, Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
Initia T3 Acetabular Hemispherical Shell System
K242045 · LPH Prosthesis, Hip,... · Orthopedic
Apr 2025 272d
Tesera-k SC System
K242928 · OVE Intervertebral Fusion... · Orthopedic
Apr 2025 198d
Tesera-k PL System and Tesera-k XL System
K242771 · MAX Intervertebral Fusion... · Orthopedic
Mar 2025 188d
Initia Knee System
K243295 · JWH Prosthesis, Knee,... · Orthopedic
Jan 2025 87d
Skyway Anterior Cervical Plate System
K243015 · KWQ Appliance, Fixation,... · Orthopedic
Nov 2024 39d
TRIBRID? Unicompartmental Knee System
K232114 · HSX Prosthesis, Knee,... · Orthopedic
Apr 2024 265d
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
K230808 · OVD Intervertebral Fusion... · Orthopedic
Apr 2023 29d
Tesera-K SC System
K223105 · OVE Intervertebral Fusion... · Orthopedic
Dec 2022 83d
Tesera-k ALIF System
K212980 · OVD Intervertebral Fusion... · Orthopedic
Jan 2022 112d
KMTI S141 Lumbar Interbody Fusion System
K212070 · MAX Intervertebral Fusion... · Orthopedic
Aug 2021 59d
KMTI Hip Replacement System
K203472 · OQG Hip Prosthesis,... · Orthopedic
Apr 2021 128d
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
K201660 · OQG Hip Prosthesis,... · Orthopedic
Jul 2020 28d
Kyocera Bipolar Hip System
K200709 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Apr 2020 30d
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
K200328 · OQG Hip Prosthesis,... · Orthopedic
Mar 2020 30d
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
K193320 · OVD Intervertebral Fusion... · Orthopedic
Feb 2020 64d
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