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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
510(k) Number K111970
Device Name KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT
Original Applicant
TORNIER
161 rue lavoisier
montbonnot
saint-ismier cedex,  FR 38334
Original Contact stephanie bernard
Regulation Number888.3540
Classification Product Code
KRR  
Date Received07/25/2011
Decision Date 02/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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