FDA applicant
Hand Innovations, Inc.
FDA records 17 decisions for Hand Innovations, Inc. (Miami Lakes, FL) from 2000 to 2006: 17 510(k) clearances. Most are in product codes LXT (Appliance, Fixation, Nail/Blade/Plate…) and HRS (Plate, Fixation, Bone). Its devices cite 17 predicates, 12 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Hand Innovations, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hand Innovations, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hand Innovations, Inc. since 2007.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Hand 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 “Hand”
FDA records each applicant name separately; these may or may not be the same firm.