FDA Registration
Active
🇺🇸 United States
Renovis Surgical Hip Replacement 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
- K171543
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 |
|---|---|---|---|---|---|
| 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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-12-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-12-28 |
Proprietary Names
Renovis Surgical Hip Replacement System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility