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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 K150372
Device Name VERASENSE Knee System
Applicant
Orthosensor, Inc.
1855 Griffin Rd. Suite A-310
Dania Beach,  FL  33004
Applicant Contact Kimberlee Washburn
Correspondent
Orthosensor, Inc.
1855 Griffin Rd. Suite A-310
Dania Beach,  FL  33004
Correspondent Contact Deborah Johnson
Regulation Number882.4560
Classification Product Code
ONN  
Date Received02/13/2015
Decision Date 04/15/2016
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
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