FDA Product Code HBE: Drills, Burrs, Trephines & Accessories (simple, Powered)

Under FDA product code HBE, neurosurgical drills, burrs, and trephines are cleared for bone removal and shaping during intracranial and spinal procedures.

These powered or manual cutting instruments are used to perform craniotomies, drill burr holes, remove bone flaps, and shape bony surfaces during neurosurgical procedures. High-speed pneumatic or electric drills with irrigating systems minimize thermal injury to surrounding neural tissue.

HBE devices are Class II medical devices, regulated under 21 CFR 882.4310 and reviewed by the FDA Neurology panel.

Leading manufacturers include Surgify Medical OY, Biomet Microfixation and Nakanishi, Inc..