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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K880227
Device Name ARTHROBOT(TM) LOWER LIMB POSITIONER
Applicant
Andronic Devices, Ltd.
Box 58382
Vancouver
Canada,  CA V6P 6E4
Applicant Contact MACNEIL P.ENG
Correspondent
Andronic Devices, Ltd.
Box 58382
Vancouver
Canada,  CA V6P 6E4
Correspondent Contact MACNEIL P.ENG
Regulation Number878.4960
Classification Product Code
FQO  
Date Received01/20/1988
Decision Date 02/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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