Kyocera Medical Technologies, Inc.
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories9
Latest Approval2025-04-10
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K242928 | Tesera-k SC System | OVE | 2025-04-10 | View |
| 510(k) | K242045 | Initia T3 Acetabular Hemispherical Shell System | LPH | 2025-04-10 | View |
| 510(k) | K242771 | Tesera-k PL System and Tesera-k XL System | MAX | 2025-03-20 | View |
| 510(k) | K243295 | Initia Knee System | JWH | 2025-01-13 | View |
| 510(k) | K243015 | Skyway Anterior Cervical Plate System | KWQ | 2024-11-05 | View |
| 510(k) | K232114 | TRIBRID® Unicompartmental Knee System | HSX | 2024-04-04 | View |
| 510(k) | K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | 2023-04-21 | View |
| 510(k) | K223105 | Tesera-K SC System | OVE | 2022-12-22 | View |
| 510(k) | K212980 | Tesera-k ALIF System | OVD | 2022-01-07 | View |
| 510(k) | K212070 | KMTI S141 Lumbar Interbody Fusion System | MAX | 2021-08-30 | View |
| 510(k) | K203472 | KMTI Hip Replacement System | OQG | 2021-04-02 | View |
| 510(k) | K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | OQG | 2020-07-16 | View |
| 510(k) | K200709 | Kyocera Bipolar Hip System | KWY | 2020-04-17 | View |
| 510(k) | K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | OQG | 2020-03-11 | View |
| 510(k) | K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | 2020-02-04 | View |
No matching devices.