Data / Medical devices / Orthopedic Stereotaxic Instrument / Israel
FDA-registered makers of Orthopedic Stereotaxic Instrument in Israel: 7 establishments
7 establishments in Israel are registered with the FDA to make Orthopedic Stereotaxic Instrument (product code OLO). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Orthopedic Stereotaxic Instrument
- Product code
- OLO
- Country
- Israel
Makers of Orthopedic Stereotaxic Instrument in Israel
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Mazor Robotics Ltd. | Caesarea Haifa, Israel | Manufacturer, Specification developer | 4 | September 11, 2025 | 0 | 4 | 0 | api.fda.gov |
| CarboFix Orthopedics, Ltd. | Herzeliya Central, Israel | Manufacturer | 2 | October 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Pathkeeper Surgical Ltd. | Kfar-Saba Central, Israel | Specification developer | 1 | March 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Premia Spine Ltd. | Ramat Poleg, Netanya Central, Israel | Manufacturer | 1 | October 8, 2019 | 0 | 0 | 0 | api.fda.gov |
| B.Y. Medimor Ltd | Tiberias Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina- Sci Israel Medical Systems Ltd. | Maalot-Tarshiha Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tamuz F.T.K. Solutions | Afula Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.