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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 K231284
Device Name OnPoint Augmented Reality Spine System
Applicant
OnPoint Surgical, Inc.
19 Crosby Drive, Suite 120
Bedford,  MA  01730
Applicant Contact Amy ODonnell
Correspondent
OnPoint Surgical, Inc.
19 Crosby Drive, Suite 120
Bedford,  MA  01730
Correspondent Contact Amy ODonnell
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/03/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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