FDA Registration
Active
🇺🇸 United States
OSTEOREMEDIES, LLC
Reg #: 3010537287
·
FEI: 3010537287
·
Expires 2026
Products
11
Proprietary Names
20
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- OSTEOREMEDIES, LLC
- Registration Number
- 3010537287
- FEI Number
- 3010537287
- Status
- Active
- Expiry Year
- 2026
- 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
- Rachel Kennedy
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 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-02-03 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2026-04-08 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2013-12-05 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-03-19 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2015-12-28 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-01-03 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2023-12-21 |
Proprietary Names
REMEDY Knee Spacer
REMEDY Hip Spacer
Remedy Spectrum GV Hip Spacer System
Remedy Acetabular Cup
Remedy Hip Spacer System
REMEDY® Stemmed Knee Spacer
REMEDY Trial
REMEDY Template
REMEDY Radel Trial
REMEDY POLY+PLUS Acetabular Cup
UNITE AB Cement
REMEDY® Poly+Plus Tibial Component
Remedy Shoulder Spacer
Remedy Spectrum GV Hip Spacer
Spectrum GV Bone Cement
OsteoRemedies Remedy Trial Tray
REMEDY CoCr Modular Femoral Head
SPECTRUM GV Bone Cement
REMEDY® STEMMED KNEE SPACER
BioBrush
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device