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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 K200384
Device Name HipXpert 3D Display and Anchoring Application
Applicant
Surgical Planning Associates, Inc
New England Baptist Hospital, 125 Parker Hill Ave Suite 545
Boston,  MA  02120
Applicant Contact Stephen B Murphy
Correspondent
Orchid Design
80 Shelton Technology Center
Shelton,  CT  06484
Correspondent Contact Kellen Hills
Regulation Number882.4560
Classification Product Code
OSF  
Date Received02/18/2020
Decision Date 01/28/2021
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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