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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthopedic stereotaxic instrument
510(k) Number K121765
Device Name SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
Original Applicant
STANMORE IMPLANTS WORLDWIDE LTD
1331 h street, nw, 12 floor
washington,  DC  20005
Original Contact hollace saas rhodes
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/15/2012
Decision Date 01/11/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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