FDA Registration
Active
🇺🇸 United States
INTREPED
Reg #: 3030271054
·
FEI: 3030271054
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- AUXANO MEDICAL LLC
- Registration Number
- 3030271054
- FEI Number
- 3030271054
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8006 Katherine Boulevard
- City
- Brecksville
- State
- OH
- ZIP
- 44141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231649
Owner / Operator
- Firm Name
- Auxano Medical LLC
- Operator Number
- 10089779
- Address
- 8006 Katherine Boulevard
- City
- Brecksville
- State
- OH
- Postal Code
- 44141
- Country
- US
- Correspondent
- Dan Filler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-01-08 |
Proprietary Names
INTREPED
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility