FDA Registration
Active
🇺🇸 United States
BIOCORE9 LLC
Reg #: 3020162561
·
FEI: 3020162561
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIOCORE9 LLC
- Registration Number
- 3020162561
- FEI Number
- 3020162561
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 30 Broad Street, Ste 3 B
- City
- Denville
- State
- NJ
- ZIP
- 07834
- Country
- US
Regulatory Submissions
- 510(k) Number
- K212761
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, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-12-29 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-12-29 |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2021-08-27 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-08-27 |
Proprietary Names
Biocore9 Acetabular Cup System
Biocore9 Femoral Head Resurfacing Component
Biocore9 Humeral Head Resurfacing System
Establishment Types
Manufacture Medical Device