SMTP

Device typeHard-tissue ultrasonic surgical system handpiece tip: A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece to amplify and deliver ultrasonic energy to mechanically fragment and cut bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It is available in a variety of sizes and forms (e.g., blade, rasp), and is not intended to be held directly; a channel for surgical waste aspiration and a covering sleeve for delivery of irrigation solution may be included. This is a single-use device.

FDA categoryInstrument, Surgical, Sonic And Accessory/Attachment

Device ID06972603519781

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyMR Unsafe