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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K090313
Device Name PIGALILEO TKR BASE V2.3 AND CAS V4.1
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact MANDY COE
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact MANDY COE
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/09/2009
Decision Date 03/11/2009
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
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