FDA Registration
Inactive
🇺🇸 United States
ORTHOPEDIC DRIVEN IMAGING, LLC
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORTHOPEDIC DRIVEN IMAGING, LLC
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4424 Nw 13th St Ste B6
- City
- Gainesville
- State
- FL
- ZIP
- 32609
- Country
- US
Regulatory Submissions
- 510(k) Number
- K260321
Owner / Operator
- Firm Name
- Orthopedic Driven Imaging, LLC
- Operator Number
- 10095857
- Address
- 4424 NW 13th Street, Suite B-6
- City
- Gainesville
- State
- FL
- Postal Code
- 32609
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2026-05-11 |
Proprietary Names
HipGuide
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility