Zimmer PSI Shoulder System Receives FDA 510(k) Clearance

Spinal Tech

Zimmer Holdings received FDA 510(k) clearance for the Patient Specific Instruments Shoulder system, which works with its Trabecular Metal Reverse Shoulder system for reverse shoulder arthroplasty procedures. The Zimmer PSI device has 3-D visualization software for surgeons to map surgical plans. Since May, surgeons in a limited number of European countries have performed shoulder procedures with the device. Now it will be available throughout the U.S.

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