FDA Registration
Active
🇺🇸 United States
Biocore9 Femoral Head Resurfacing Component
Reg #: 3020162561
·
FEI: 3020162561
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIOCORE9 LLC
- Registration Number
- 3020162561
- FEI Number
- 3020162561
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 30 Broad Street, Ste 3 B
- City
- Denville
- State
- NJ
- ZIP
- 07834
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201219
Owner / Operator
- Firm Name
- Biocore9 LLC
- Operator Number
- 10082626
- Address
- 30 Broad Street, Ste 3 B
- City
- Denville
- State
- NJ
- Postal Code
- 07834
- Country
- US
- Correspondent
- Stan Matlak
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2021-08-27 |
Proprietary Names
Biocore9 Femoral Head Resurfacing Component
Establishment Types
Manufacture Medical Device