FDA 510(k) Applications Submitted by Kyocera Medical Technologies, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200328 |
02/10/2020 |
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System |
Kyocera Medical Technologies, Inc. |
| K200709 |
03/18/2020 |
Kyocera Bipolar Hip System |
Kyocera Medical Technologies, Inc. |
| K201660 |
06/18/2020 |
KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System |
Kyocera Medical Technologies, Inc. |
| K212070 |
07/02/2021 |
KMTI S141 Lumbar Interbody Fusion System |
Kyocera Medical Technologies, Inc. |
| K203472 |
11/25/2020 |
KMTI Hip Replacement System |
Kyocera Medical Technologies, Inc. |
| K193320 |
12/02/2019 |
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System |
Kyocera Medical Technologies, Inc. |
| K243295 |
10/18/2024 |
Initia Knee System |
Kyocera Medical Technologies, Inc. |
| K242771 |
09/13/2024 |
Tesera-k PL System and Tesera-k XL System |
Kyocera Medical Technologies, Inc. |
| K242928 |
09/24/2024 |
Tesera-k SC System |
Kyocera Medical Technologies, Inc. |
| K243015 |
09/27/2024 |
Skyway Anterior Cervical Plate System |
Kyocera Medical Technologies, Inc. |
| K230808 |
03/23/2023 |
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System |
Kyocera Medical Technologies, Inc. |
| K212980 |
09/17/2021 |
Tesera-k ALIF System |
Kyocera Medical Technologies, Inc. |
| K223105 |
09/30/2022 |
Tesera-K SC System |
Kyocera Medical Technologies, Inc. |
| K242045 |
07/12/2024 |
Initia T3 Acetabular Hemispherical Shell System |
Kyocera Medical Technologies, Inc. |
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