FDA Registration
Active
🇲🇽 Mexico
VariTrax Sternal Circumfixator
Reg #: 3030517273
·
FEI: 3030517273
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GALAZ SCIENCE AND ENGINEERING S.S. DE C.V.
- Registration Number
- 3030517273
- FEI Number
- 3030517273
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- San pedro de los pinos #86 Suite #1
- City
- Hermosillo Sonora
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K232986
Owner / Operator
- Firm Name
- Galaz Science and Engineering S.S. de C.V.
- Operator Number
- 10090188
- Address
- San pedro de los pinos #86 Suite #1
- City
- Hermosillo
- State
- Sonora
- Postal Code
- 83304
- Country
- MX
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2024-02-26 |
Proprietary Names
VariTrax Sternal Circumfixator
VariTrax
VSC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)