FDA Registration
Active
🇺🇸 United States
UNIK ORTHOPEDICS, INC
Reg #: 3019006180
·
FEI: 3019006180
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- UNIK ORTHOPEDICS, INC
- Registration Number
- 3019006180
- FEI Number
- 3019006180
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1701 Fortune Drive, Suite E
- City
- San Jose
- State
- CA
- ZIP
- 95131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240327
Owner / Operator
- Firm Name
- Unik Orthopedics, Inc
- Operator Number
- 10081722
- Address
- 1701 Fortune Drive, Suite E
- City
- San Jose
- State
- CA
- Postal Code
- 95131
- Country
- US
- Correspondent
- Charlie Chi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-11-07 |
| Knee Arthroplasty Implantation System | OOG | Class 2 | Orthopedic | No | 2024-11-07 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-11-07 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-05-10 |
Proprietary Names
UNIKO PointCloud Knee Instruments
Vault System Surgery Planning Software
Establishment Types
Manufacture Medical Device