FDA Registration
Active
🇺🇸 United States
Klassic Sombrero Patella with E-Link, Size 5, 10mm thickness
Reg #: 3008544874
·
FEI: 3008544874
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- TOTAL JOINT ORTHOPEDICS, INC.
- Registration Number
- 3008544874
- FEI Number
- 3008544874
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1567 E. Stratford Avenue
- City
- Salt Lake City
- State
- UT
- ZIP
- 84106
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190280
Owner / Operator
- Firm Name
- Total Joint Orthopedics, Inc
- Operator Number
- 10036774
- Address
- 1567 E. Stratford Avenue
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84106
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2019-04-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-04-04 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2019-04-04 |
Proprietary Names
Klassic Sombrero Patella with E-Link, Size 5, 10mm thickness
Klassic Sombrero Patella, Size 5, 10mm thickness
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility