FDA applicant
Rebotix
FDA records 5 decisions for Rebotix (St. Petersburg, FL) from 2024 to 2025: 5 510(k) clearances. All are in product code QSM (System, Surgical, Computer Controlled…). Since 2016 its 510(k)s took a median of 188 days from receipt to decision, against 188 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 0 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 Rebotix’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Rebotix’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