FDA Registration
Active
🇺🇸 United States
Vitoss BiModal Bioactive Bone Graft Substitute
Reg #: 3004024955
·
FEI: 3004024955
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- STRYKER SPINE
- Registration Number
- 3004024955
- FEI Number
- 3004024955
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 PEARL COURT
- City
- ALLENDALE
- State
- NJ
- ZIP
- 07401
- Country
- US
Regulatory Submissions
- 510(k) Number
- K103173
Owner / Operator
- Firm Name
- VB Spine, LLC
- Operator Number
- 10093189
- Address
- 505 Park Avenue, 14th Floor
- City
- New York
- State
- NY
- Postal Code
- 10022
- Country
- US
- Correspondent
- Christopher Tortora
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2025-04-17 |
Proprietary Names
Vitoss BiModal Bioactive Bone Graft Substitute
Vitoss BBTrauma Bioactive Bone Graft Substitute
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility