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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 K262253
Device Name Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
Applicant
Orthalign, Inc.
153 Technology
Irvine,  CA  92618
Applicant Contact Michaela Lindemann
Correspondent
Orthalign, Inc.
153 Technology
Irvine,  CA  92618
Correspondent Contact Michaela Lindemann
Regulation Number882.4560
Classification Product Code
ONN  
Subsequent Product Code
OLO  
Date Received07/02/2026
Decision Date 07/31/2026
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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