FDA Registration
Active
🇺🇸 United States
OsteoBallast MT
Reg #: 3006121828
·
FEI: 3006121828
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- POLY-MED, INC.
- Registration Number
- 3006121828
- FEI Number
- 3006121828
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 52 Technology Dr
- City
- Anderson
- State
- SC
- ZIP
- 29625
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200290
Owner / Operator
- Firm Name
- Poly-Med, Inc.
- Operator Number
- 10034488
- Address
- 51 Technology Drive
- City
- Anderson
- State
- SC
- Postal Code
- 29625
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2021-08-25 |
Proprietary Names
OsteoBallast MT
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)