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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 K090953
Device Name TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
Applicant
PRAXIM MEDIVISION, SA
LE GRAND SABLON
4 AVENUE DE L'OBIOU
LA TRONCHE,  FR 38700
Applicant Contact SEBASTIEN BURTIN
Correspondent
PRAXIM MEDIVISION, SA
LE GRAND SABLON
4 AVENUE DE L'OBIOU
LA TRONCHE,  FR 38700
Correspondent Contact SEBASTIEN BURTIN
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/03/2009
Decision Date 01/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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