FDA Registration
Active
🇺🇸 United States
Xia Stainless Steel Spinal System
Reg #: 3004024955
·
FEI: 3004024955
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
3
Classifications
4
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
- K031893
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 |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-04-18 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-04-18 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-04-18 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-04-18 |
Proprietary Names
Xia Stainless Steel Spinal System
Xia Titanium Spinal System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device