FDA applicant
Orthohelix Surgical Designs, Inc.
FDA records 25 decisions for Orthohelix Surgical Designs, Inc. (Medina, OH) from 2005 to 2014: 25 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Its devices cite 66 predicates, 28 of them its own earlier devices. 12 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Orthohelix Surgical Designs, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2014
2026 so far, outlined.
Recalls per year
2in 2011
Class I Class II/III not classified
Planning a device like Orthohelix Surgical Designs, 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