FDA Registration
Active
🇺🇸 United States
Klassic HD Acetabular Inserts with XLPE
Reg #: 3008544874
·
FEI: 3008544874
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
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
- K161073
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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2016-10-20 |
Proprietary Names
Klassic HD Acetabular Inserts with XLPE
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility