SIGNUS FDA 510(k) Clearance for DIPLOMAT Posterior Pedicle Screw
SIGNUS Medizintechnik announced FDA 510(k) clearance to market the DIPLOMAT® pedicle screw system.
DIPLOMAT launched ex-U.S. in 2015. The system comprises a modular two-piece implant, with pedicle screws to be assembled as required with the appropriate tulips. If necessary, the tulips may be removed and replaced in situ during surgery. The ELASTOLOK® locking mechanism ensures high strength for the screw/tulip connection.
Sources: SIGNUS Medizintechnik; ORTHOWORLD Inc.