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The LB Medical Inflatable Tissue Elevator/Expander System is a surgical tool intended for use as a conventional manual elevator for orthopaedic or general surgery, including use to access the carpal tunnel region during carpal tunnel release procedures.

The subject device is similar to a traditional elevator, but features a manually inflatable balloon component at the distal end. The balloon is inflated/deflated with saline via a manual inflation syringe system with an integral pressure gauge.

BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION

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The intended use of the Spacemaker® Surgical Balloon Dissector/Expander is to create a surgical space anywhere in the body by dissecting layers of connective tissue along natural planes of separation and provide intraoperative and subsequent tissue expansion. The Spacemaker® Surgical Balloon Dissector/Expander is a temporary subcutaneous or submuscular implant device. The indications for use include the following: breast reconstruction, limb reconstruction, correction of congenital deformities and cosmetic defects, and scar revision.

The Spacemaker® Surgical Balloon Dissector/Expander device is a handheld, manually manipulated surgical balloon device which dissects tissue planes, intraoperatively and subsequently expands the overlying tissue. This device is a temporary subcutaneous or submuscular implant device. The Spacemaker® Surgical Balloon Dissector/Expander is a single use, disposable device provided sterile to the physician. The major components of the device are a balloon dissector and an injection port/connector.