FDA applicant
CarboFix Orhtopedics, Ltd.
FDA records 1 decision for CarboFix Orhtopedics, Ltd. (Herzeliya, IL) in 2026: 1 510(k) clearance. All are in product code OLO (Orthopedic Stereotaxic Instrument). 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 CarboFix Orhtopedics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like CarboFix Orhtopedics, 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) ReportOther applicant names beginning “CarboFix”
FDA records each applicant name separately; these may or may not be the same firm.