Profile: Inspire Medical Systems, Inc., specializes in the production of implantable therapeutic devices for the treatment of obstructive sleep apnea. Our Inspire II system consists of an implantable pulse generator, a pulmonary pressure sensor and a stimulation lead that delivers the electrical impulses to the patients hypoglossal nerve. It senses a patient's respiratory effort during sleep and provides hypoglossal nerve stimulation to maintain an open airway synchronous with respiration. Our physician controller unit used during visits to the patients treating physician & used to monitor the therapy and make adjustments to the device as needed for the patient's unique physiology.
FDA Registration Number: 3007666314
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• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Implantable Stimulation Leads for Cardiac Rhythm Management |
• Implantable Therapeutic Devices |
• Pressure Sensor Systems |
• Pulse Generators |
• Sleep Apnea Equipment |