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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoperative Orthopedic Joint Assessment Aid
510(k) Number K253507
Device Name Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
Applicant
Orthalign, Inc.
153 Technology
Irvine,  CA  92608
Applicant Contact Michaela Lindemann
Correspondent
Orthalign, Inc.
153 Technology
Irvine,  CA  92608
Correspondent Contact Michaela Lindemann
Regulation Number882.4560
Classification Product Code
ONN  
Date Received11/03/2025
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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