FDA Registration
Active
🇺🇸 United States
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Reg #: 3015398319
·
FEI: 3007932279
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Kyocera Medical Technologies, Inc.
- Registration Number
- 3015398319
- FEI Number
- 3007932279
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1289 Bryn Mawr Ave Ste A
- City
- Redlands
- State
- CA
- ZIP
- 92374
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200328
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 |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-12-13 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2022-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-12-13 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2022-12-13 |
Proprietary Names
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198