FDA Product Code PLF: Bone Wedge
FDA product code PLF covers bone wedges used as grafts or spacers in orthopedic procedures.
These shaped bone or synthetic spacers are used with ancillary fixation to correct angular deformities, restore joint alignment, and fill bone defects created during corrective osteotomies and revision surgery. They are commonly used in high tibial osteotomy and distal femoral osteotomy.
PLF devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Nvision Biomedical Technologies, Inc., Paragon 28, Inc. and MiRus, LLC.
List of Bone Wedge devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Bone Wedge devices (product code PLF). 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 →