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January 22, 2013
16:21 EDTMAKOFDA determines Stanmore Sculptor RGA 'substantially equivalent'
In a decision dated Jan. 11, 2013, the FDA determined that the Sculptor Robotic Guidance Arm is substantially equivalent to a device already placed into one of the three classification categories. The Sculptor RGA system is a robotic guide to assist with bone preparation to receive patient specific implants designed by Stanmore Implants, according to Stanmore's corporate site. MAKO Surgical (MAKO) is a medical device company that markets the RIO Robotic Arm Interactive Orthopedic system and orthopedic implants. Reference Link
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