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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K061362
Device Name PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM
Applicant
Plus Orthopedics AG
18 Bridie Ln.
Norfolk,  MA  02056
Applicant Contact PAMELA J WEAGRAFF
Correspondent
Plus Orthopedics AG
18 Bridie Ln.
Norfolk,  MA  02056
Correspondent Contact PAMELA J WEAGRAFF
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/16/2006
Decision Date 10/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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