FDA Registration
Active
🇺🇸 United States
REMEDY Knee Spacer
Reg #: 3010537287
·
FEI: 3010537287
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OSTEOREMEDIES, LLC
- Registration Number
- 3010537287
- FEI Number
- 3010537287
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6800 Poplar Ave Ste 120
- City
- Memphis
- State
- TN
- ZIP
- 38138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112470
Owner / Operator
- Firm Name
- Osteoremedies, LLC
- Operator Number
- 10045273
- Address
- 6800 Poplar Ave, Suite 120
- City
- Memphis
- State
- TN
- Postal Code
- 38138
- Country
- US
- Correspondent
- Chris Hughes
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2013-11-01 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-11-01 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-11-01 |
| Bone Cement, Antibiotic | MBB | Class 2 | Orthopedic | No | 2013-11-01 |
Proprietary Names
REMEDY Knee Spacer
REMEDY Hip Spacer
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility