FDA Product Code OWI: Bone Fixation Cerclage, Sublaminar
FDA product code OWI covers sublaminar bone fixation cerclage systems used in spinal surgery.
These cables or wires are passed beneath the laminae of the spine to serve as bone anchors for spinal instrumentation constructs, particularly in cases where pedicle screw fixation is not feasible due to anatomy, bone quality, or prior surgery.
OWI devices are Class II medical devices, regulated under 21 CFR 888.3010 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medtronic, Inc., Medicrea International SA and Astura Medical.
List of Bone Fixation Cerclage, Sublaminar devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Bone Fixation Cerclage, Sublaminar devices (product code OWI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →