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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 K200892
Device Name Harvey(R) Surgical Assistant
Applicant
Orthalign, Inc.
120 Columbia Suite 500
Aliso Viejo,  CA  92656
Applicant Contact Karyl Haskell
Correspondent
Orthalign, Inc.
120 Columbia Suite 500
Aliso Viejo,  CA  92656
Correspondent Contact Karyl Haskell
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/03/2020
Decision Date 06/18/2020
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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