FDA applicant
Bonutti Research, Inc.
FDA records 17 decisions for Bonutti Research, Inc. (Effingham, IL) from 1997 to 2016: 17 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Its devices cite 25 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Bonutti Research”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bonutti Research, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Bonutti Research, Inc.’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