FDA Registration
Active
🇺🇸 United States
HyProCure Sinus Tarsi Stent System
Reg #: 3004993707
·
FEI: 3004993707
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Graham Medical Technologies, L.L.C. d.b.a. GraMedica
- Registration Number
- 3004993707
- FEI Number
- 3004993707
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 16137 Leone Drive
- City
- Macomb
- State
- MI
- ZIP
- 48042
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042030
Owner / Operator
- Firm Name
- GRAMEDICA
- Operator Number
- 9069880
- Address
- 16137 Leone Drive, --
- City
- Macomb
- State
- MI
- Postal Code
- 48042
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2007-11-02 |
Proprietary Names
HyProCure Sinus Tarsi Stent System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device