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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 K090474
Device Name ORTHOREX INTRA-OPERATIVE LOAD SENSOR
Applicant
Orthosensor, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact JON WARD
Correspondent
Orthosensor, Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact JON WARD
Regulation Number882.4560
Classification Product Code
ONN  
Date Received02/24/2009
Decision Date 10/19/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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