FDA Product Code HTN: Washer, Bolt Nut
FDA product code HTN covers washers, bolts, and nuts used as components of orthopedic fixation constructs.
These hardware components provide load distribution, locking, and mechanical interface functions within complex fracture fixation systems. They are used in conjunction with bone screws, plates, and rods to create stable constructs for the treatment of complex fractures and deformities.
HTN devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Arthrex, Inc., TriMed, Inc. and Acumed, LLC.
List of Washer, Bolt Nut devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Washer, Bolt Nut devices (product code HTN). 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 →