15f0f375-f489-45f5-9794-ae9c889de127UpdatePublished22020-10-092020-06-17In Commercial Distribution00844856042575PrimaryGS1Illico73707602465783ALPHATEC SPINE, INC.1SE DILATOR 1falsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(760)431-9286Regulatory@alphatecspine.com45181Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.falseActiveGADRETRACTORfalsetrueMoist Heat or Steam Sterilization