Kyocera Medical Technologies, Inc.
Redlands, CA, US
Kyocera Medical Technologies, Inc. appears in FDA device records in Redlands, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Kyocera Medical Technologies, Inc. between 2020 and 2026. The busiest year on record is 2020, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 4 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 4 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | OVD | Substantially Equivalent | |
| K242928 | Tesera-k SC System | OVE | Substantially Equivalent | |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | LPH | Substantially Equivalent | |
| K242771 | Tesera-k PL System and Tesera-k XL System | MAX | Substantially Equivalent | |
| K243295 | Initia Knee System | JWH | Substantially Equivalent | |
| K243015 | Skyway Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K232114 | TRIBRID® Unicompartmental Knee System | HSX | Substantially Equivalent | |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Substantially Equivalent | |
| K223105 | Tesera-K SC System | OVE | Substantially Equivalent | |
| K212980 | Tesera-k ALIF System | OVD | Substantially Equivalent | |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | MAX | Substantially Equivalent | |
| K203472 | KMTI Hip Replacement System | OQG | Substantially Equivalent | |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | OQG | Substantially Equivalent | |
| K200709 | Kyocera Bipolar Hip System | KWY | Substantially Equivalent | |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | OQG | Substantially Equivalent | |
| K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | OVD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015398319 | 3007932279 | Kyocera Medical Technologies, Inc. | 1289 Bryn Mawr Ave Ste A, Redlands, CA 92374 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWCScrew, Fixation, Bone
- HTNWasher, Bolt Nut
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain