FDA Registration
Active
🇺🇸 United States
BioPoly Great Toe Hemiarthroplasty Implant
Reg #: 3008108789
·
FEI: 3008108789
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOPOLY, LLC
- Registration Number
- 3008108789
- FEI Number
- 3008108789
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7136 Gettysburg Pike
- City
- Fort Wayne
- State
- IN
- ZIP
- 46804
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203634
Owner / Operator
- Firm Name
- BioPoly, LLC
- Operator Number
- 10041050
- Address
- 7136 Gettysburg Pike
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46804
- Country
- US
- Correspondent
- Herb E Schwartz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2021-10-19 |
Proprietary Names
BioPoly Great Toe Hemiarthroplasty Implant
Establishment Types
Manufacture Medical Device