FDA Registration
Active
🇺🇸 United States
Kyocera Medical Technologies, Inc.
Reg #: 3015398319
·
FEI: 3007932279
·
Expires 2026
Products
21
Proprietary Names
32
Establishment Types
2
Classifications
21
Registration Details
- Registration Name
- Kyocera Medical Technologies, Inc.
- Registration Number
- 3015398319
- FEI Number
- 3007932279
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1289 Bryn Mawr Ave Ste A
- City
- Redlands
- State
- CA
- ZIP
- 92374
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113084
Owner / Operator
- Firm Name
- Kyocera Medical Technologies, Inc.
- Operator Number
- 10030880
- Address
- 1289 Bryn Mawr Avenue, Suite A
- City
- Redlands
- State
- CA
- Postal Code
- 92374
- Country
- US
- Correspondent
- Anthony DeBenedictis
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2013-01-03 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-03 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2017-12-28 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2017-12-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-12-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-12-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2010-12-17 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2010-12-17 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2010-12-17 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-11-18 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-08-15 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-08-15 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-01-16 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2019-01-16 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-03-11 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2013-03-11 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2011-12-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-03-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2014-12-11 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2024-04-15 |
Proprietary Names
Renovis Cannulated Screw System
Renovis Surgical Hip Replacement System
Renovis S100 Pedicle Screw System
Renovis A400 Hip Joint Replacement Prosthesis
Renovis Anterior Cervical Plate System
Tesera-k PL System and Tesera-k XL System
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
Kyocera Bipolar Hip System
Skyway Anterior Cervical Plate System
Renovis S141 Lumbar Interbody Cage System
PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
A 200 Knee System
Renovis T710 Large External Fixation System
Initia T3 Acetabular Hemispherical Shell System
S 128 Anterior Lumbar Interbody Fusion (ALIF) System
Renovis S180 Lateral Lumbar Interbody Fusion System
KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM
Tesera-k ALIF System
Kyocera Medical Technologies, Inc.
A 200 PS Knee System
RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
RENOVIS CEMENTED HIP SYSTEM
TRIBRID Unicompartmental Knee System
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
S 150 Stand-Alone Cervical Interbody System
KMTI S141 Lumbar Interbody Fusion System
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
S141 Lumbar Interbody Fusion System
Tesera-K SC System
S128 Anterior Lumbar Interbody Fusion (ALIF) System
Renovis Bipolar Hip Replacement System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198