FDA applicant
Small Bone Innovations, Inc.
FDA records 24 decisions for Small Bone Innovations, Inc. (New York, NY) from 2005 to 2013: 24 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 14 predicates, 1 of them its own earlier devices. 39 recalls are linked to its devices.
FDA’s records also spell it “Small Bone Innovations, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Small Bone Innovations, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
31in 2017
Class I Class II/III not classified
Planning a device like Small Bone Innovations, 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) ReportOther applicant names beginning “Small”
FDA records each applicant name separately; these may or may not be the same firm.