FDA applicant
Orthomatrix, Inc.
FDA records 8 decisions for Orthomatrix, Inc. (Collierville, TN) from 1984 to 2001: 8 510(k) clearances. Most are in product codes LYC (Bone Grafting Material, Synthetic) and HSB (Rod, Fixation, Intramedullary And Accessories). 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 Orthomatrix, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Orthomatrix, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orthomatrix, 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