FDA Registration
Active
🇺🇸 United States
Klassic Tibial Insert, PS-Max, Standard Poly
Reg #: 3008544874
·
FEI: 3008544874
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
2
Classifications
2
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
- K202740
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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-11-30 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-11-30 |
Proprietary Names
Klassic Tibial Insert, PS-Max, Standard Poly
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198