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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Augmented Reality
510(k) Number K241870
Device Name OnPoint Augmented Reality Spine System
Applicant
OnPoint Surgical, Inc.
555 Virginia Rd
Suite 103
Concord,  MA  01742
Applicant Contact Amy O'Donnell
Correspondent
OnPoint Surgical, Inc.
555 Virginia Rd
Suite 103
Concord,  MA  01742
Correspondent Contact Amy O'Donnell
Regulation Number882.4560
Classification Product Code
SBF  
Date Received06/27/2024
Decision Date 08/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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