6390ac3a-1ee4-40c6-a761-43d575c2286eNewPublished12022-09-122022-09-02In Commercial Distribution08055060728786PrimaryGS1"Alphatec (Manufacturer:Tsunami Medical)"TVN 11/15435819002TSUNAMI SRL1falsetruefalsefalsefalsetruetruetruetruetruefalsefalsefalseLabeling does not contain MRI Safety Informationfalsefalse46750Vertebral bone biopsy procedure kit, single-useA collection of sterile devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a single-use device.falseActiveGDFGuide, Needle, Surgicaltruefalse