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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patient Specific Manual Orthopedic Stereotaxic System
510(k) Number K093491
Device Name HIP SEXTANT INSTRUMENT SYSTEM
Applicant
Surgical Planning Associates
80 Shelton Technology Center
Medford,  MA  02155
Applicant Contact JOSEPH AZARY
Correspondent
Surgical Planning Associates
80 Shelton Technology Center
Medford,  MA  02155
Correspondent Contact JOSEPH AZARY
Regulation Number882.4560
Classification Product Code
OSF  
Date Received11/10/2009
Decision Date 12/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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