Data / Medical devices / United States / Orthopedic Driven Imaging, LLC
Orthopedic Driven Imaging, LLC: FDA-registered device maker in Gainesville, FL, United States, 1 510(k) clearance
Orthopedic Driven Imaging, LLC is registered with the FDA (registration 3045159436) in Gainesville, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3045159436
- Address
- 4424 Nw 13th St Ste B6, Gainesville, FL, United States, 32609
- Owner or operator
- Orthopedic Driven Imaging, LLC (10095857)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- May 11, 2026
- Registered through
- 2026
- Brand names listed
- HipGuide
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 8, 2026 | K260321 | HipGuide (V 1.0.0.0) | LLZ | Substantially Equivalent | Orthopedic Driven Imaging, LLC | accessdata.fda.gov |
Compare with other makers
Updated May 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.