FDA Registration
Active
🇺🇸 United States
ASTRA ORTHOMED, INC.
Reg #: 3041501961
·
FEI: 3041501961
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ASTRA ORTHOMED, INC.
- Registration Number
- 3041501961
- FEI Number
- 3041501961
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7842 Hickory Flat Hwy
- City
- Woodstock
- State
- GA
- ZIP
- 30188
- Country
- US
Regulatory Submissions
- 510(k) Number
- K251382
Owner / Operator
- Firm Name
- Astra OrthoMed, Inc.
- Operator Number
- 10094256
- Address
- 7842 Hickory Flat Hwy
- City
- Woodstock
- State
- GA
- Postal Code
- 30188
- Country
- US
- Correspondent
- Michael Graham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2025-11-20 |
Proprietary Names
Phoenix Sinus Tarsi Stent System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility