FDA Registration
Active
🇬🇧 United Kingdom
Synicem Shoulder Spacer with Gentamicin
Reg #: 9617083
·
FEI: 3002806534
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- BIOCOMPOSITES LTD.
- Registration Number
- 9617083
- FEI Number
- 3002806534
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KEELE SCIENCE PARK
- City
- Keele Staffordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K242865
Owner / Operator
- Firm Name
- BIOCOMPOSITES LTD.
- Operator Number
- 9032315
- Address
- Keele Science Park, --
- City
- Keele
- State
- Staffordshire
- Postal Code
- ST5 5NL
- Country
- GB
- Correspondent
- Ciara - Airey
US Agent
- Business Name
- BIOCOMPOSITES, INC.
- Contact Name
- Kathleen Moon
- Address
- SUITE 320, 700 MILITARY CUTOFF ROAD
- City
- WILMINGTON
- State
- NC
- ZIP
- 28405
- Country
- US
- [email protected]
- Phone
- 910 3508015 ext. 0
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2025-07-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-07-04 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2025-07-04 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-07-04 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2025-07-04 |
Proprietary Names
Synicem Shoulder Spacer with Gentamicin
Synicem Knee Spacer with Gentamicin
Synicem Hip Spacer with Gentamicin
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility