Data / Medical devices / United States / Medivis, Inc.
Medivis, Inc.: FDA-registered device maker in New York, NY, United States, 3 510(k) clearances
Medivis, Inc. is registered with the FDA (registration 3015536273) in New York, NY, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 21, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015536273
- Address
- 259 W 30th St Fl 11, New York, NY, United States, 10001
- Owner or operator
- MEDIVIS, Inc. (10060771)
- Roles
- Manufacturer
- First device listed
- June 21, 2019
- Registered through
- 2027
- Brand names listed
- Cranial Navigation System, Spine Navigation System, SurgicalAR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | 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 |
|---|---|---|---|---|---|---|
| October 21, 2025 | K231897 | NeuroAlign software | HAW | Substantially Equivalent | Medivis, Inc. | accessdata.fda.gov |
| July 26, 2024 | K233725 | Spine Navigation System | OLO | Substantially Equivalent | Medivis, Inc. | accessdata.fda.gov |
| May 13, 2019 | K190764 | SurgicalAR | LLZ | Substantially Equivalent | Medivis, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Neurological Stereotaxic Instrument
- All makers of Orthopedic Stereotaxic Instrument
Updated October 21, 2025. 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.