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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 K093998
Device Name KNEEALIGN SYSTEM WITH REFERENCE SENSOR
Applicant
Orthalign, Inc.
338 Vista Madera
Newport Beach,  CA  92660
Applicant Contact AMY WALTERS
Correspondent
Orthalign, Inc.
338 Vista Madera
Newport Beach,  CA  92660
Correspondent Contact AMY WALTERS
Regulation Number882.4560
Classification Product Code
OLO  
Date Received12/28/2009
Decision Date 03/22/2010
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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