FDA applicant
CarboFix Orthopedics, Ltd.
FDA records 32 decisions for CarboFix Orthopedics, Ltd. (Herzeliya, IL) from 2011 to 2026: 32 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 62 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 189 predicates, 65 of them its own earlier devices. 1 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 Orthopedics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2024
2026 so far, outlined.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like CarboFix Orthopedics, 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.