FDA Registration
Active
🇸🇪 Sweden
BONE SUPPORT AB
Reg #: 3005304945
·
FEI: 3005304945
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- BONE SUPPORT AB
- Registration Number
- 3005304945
- FEI Number
- 3005304945
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SCHEELEVAGEN 19
- City
- LUND Skane
- Country
- SE
Regulatory Submissions
- 510(k) Number
- DEN210044
Owner / Operator
- Firm Name
- BONE SUPPORT AB
- Operator Number
- 9075333
- Address
- SCHEELEVAGEN 19, --
- City
- LUND
- State
- SE-NOTA
- Postal Code
- SE-22370
- Country
- SE
- Correspondent
- Blerta - Shuka
US Agent
- Business Name
- BONESUPPORT INC
- Contact Name
- Mike Roth
- Address
- 117, 4th Avenue, Suite 202
- City
- Needham
- State
- MA
- ZIP
- 02494
- Country
- US
- [email protected]
- Phone
- 781 9433452
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside | QRR | Class 2 | Orthopedic | No | 2022-06-03 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2020-12-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-10-28 |
Proprietary Names
CERAMENT G
CERAMENT BONE VOID FILLER
CERAMENT BEAD TRAY
CERAMENT BEAD TRAY
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device