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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 K070731
Device Name PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM
Applicant
PLUS ORTHOPEDICS AG
18 BRIDIE LANE
NORFOLK,  MA  02056
Applicant Contact PAMELA J WEAGRAFF
Correspondent
PLUS ORTHOPEDICS AG
18 BRIDIE LANE
NORFOLK,  MA  02056
Correspondent Contact PAMELA J WEAGRAFF
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/15/2007
Decision Date 07/31/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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