FDA applicant
Zygofix, Ltd.
FDA records 2 decisions for Zygofix, Ltd. (Misgav, IL) in 2024: 2 510(k) clearances. All are in product code MRW (System, Facet Screw Spinal Device). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zygofix, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2024high 2 (2024) · low 0 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Zygofix, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report