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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 K233315
Device Name HipXpert and HipInsight System
Applicant
Surgical Planning Associates, Inc
New England Baptist Hospital
125 Parker Hill Ave Suite 545
Boston,  MA  02120
Applicant Contact Stephen Murphy
Correspondent
Hills Quality and Regulatory Services, LLC
8971 Oakwood Lane
Olive Branch,  MS  38654
Correspondent Contact Kellen Hills
Regulation Number882.4560
Classification Product Code
OSF  
Subsequent Product Code
SBF  
Date Received09/29/2023
Decision Date 08/08/2024
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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