FDA Registration
Active
🇺🇸 United States
SImmetry SIJ Joint Fusion System
Reg #: 3027390975
·
FEI: 3027390975
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- SIVANTAGE, INC.
- Registration Number
- 3027390975
- FEI Number
- 3027390975
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 14502 N Dale Mabry Hwy Ste 200
- City
- Tampa
- State
- FL
- ZIP
- 33618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K110512
Owner / Operator
- Firm Name
- SiVantage, Inc.
- Operator Number
- 10088110
- Address
- 14502 North Mabry Hwy, Suite 200
- City
- Tampa
- State
- FL
- Postal Code
- 33618
- Country
- US
- Correspondent
- Brian Dense
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-05-30 |
Proprietary Names
SImmetry SIJ Joint Fusion System
SImmetry SI Joint Fusion System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device