Data / Medical devices / Israel / ZygoFix
ZygoFix: FDA-registered device maker in D.N. Misgav Northern, Israel, 2 510(k) clearances
ZygoFix is registered with the FDA (registration 3031232974) in D.N. Misgav Northern, Israel. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated September 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031232974
- Address
- 17 Tchelet Street Misgav Industrial Park, D.N. Misgav Northern, Israel, 2017400
- Owner or operator
- Qsite (10090737)
- Roles
- Manufacturer
- First device listed
- May 21, 2024
- Registered through
- 2026
- Brand names listed
- zLOCK Lumbar Facet Fixation System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Facet Screw Spinal Device | MRW | U | 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 |
|---|---|---|---|---|---|---|
| September 20, 2024 | K242650 | zLOCK Lumbar Facet Fixation System | MRW | Substantially Equivalent | Zygofix , Ltd. | accessdata.fda.gov |
| April 18, 2024 | K240085 | zLOCK Lumbar Facet Fixation System | MRW | Substantially Equivalent | Zygofix , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 20, 2024. 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.