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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 K130380
Device Name ORTHOSENSOR KNEE BALANCER
Applicant
ORTHOSENSOR, INC.
1560 SAWGRASS CORPORATE PKWY.
4TH FLOOR
SUNRISE,  FL  33323
Applicant Contact KIMBERLEE WASHBURN
Correspondent
ORTHOSENSOR, INC.
1560 SAWGRASS CORPORATE PKWY.
4TH FLOOR
SUNRISE,  FL  33323
Correspondent Contact KIMBERLEE WASHBURN
Regulation Number882.4560
Classification Product Code
ONN  
Date Received02/14/2013
Decision Date 06/13/2013
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
Recalls CDRH Recalls
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