Data / Medical devices / United States / Orthogrid Systems, Inc
Orthogrid Systems, Inc: FDA-registered device maker in Midvale, UT, United States, 4 510(k) clearances
Orthogrid Systems, Inc is registered with the FDA (registration 3010342382) in Midvale, UT, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 29, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010342382
- Address
- 7026 S Commerce Park Dr Suite #200, Midvale, UT, United States, 84047
- Owner or operator
- OrthoGrid Systems, Inc. (10044516)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 13, 2017
- Registered through
- 2027
- Brand names listed
- OrthoGrid 12-inch Calibration Array, OrthoGrid 9-inch Calibration Array, OrthoGrid Hip AI 4, OrthoGrid Trauma, PhantomMSK, PhantomMSK Hip, PhantomMSK Hip Preservation, PhantomMSK Hip, OrthoGrid Hip, PhantomMSK Hip Preservation, OrthoGrid Hip Preservation
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Quality-Assurance, Radiologic | LHO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer | 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 29, 2026 | K260077 | OrthoGrid Hip AI® 4.0 | QIH | Substantially Equivalent | OrthoGrid Systems, Inc. | accessdata.fda.gov |
| February 18, 2021 | K210136 | PhantomMSK Hip | LLZ | Substantially Equivalent | OrthoGrid Systems, Inc. | accessdata.fda.gov |
| December 7, 2019 | K192279 | PhantomMSK Trauma | LLZ | Substantially Equivalent | OrthoGrid Systems, Inc. | accessdata.fda.gov |
| February 15, 2019 | K182332 | PhantomMSK | LLZ | Substantially Equivalent | OrthoGrid Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
- All makers of Instrument, Quality-Assurance, Radiologic
- All makers of Medical Device Data System
Updated May 29, 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.