Able Medical Gets FDA 510(k) Clearance for Its MACH Screw Clip System
Marquette, Mich.-based Able Medical Devices has received 510(k) clearance from the FDA for its MACH screw clip system, a single-use, sterile screw-delivery system for thoracic surgical procedures.
The device, which is clipped directly onto the company’s Valkyrie thoracic-fixation system, is preloaded with screws in a modular two- or four-screw configuration.
By eliminating the need to individually load screws, “we’ve removed procedural steps and increased efficiency, thus saving time in the O.R. and the associated costs,” said Wade DePas, Able Medical’s director of quality and product development.