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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis
De Novo Number DEN220012
Device Name Tornier Pyrocarbon Humeral Head
Requester
Tornier SAS
161 rue lavoisier
montbonnot st. martin,  FR 38330
Contact loucinda bjorklund
Regulation Number888.3695
Classification Product Code
QKW  
Date Received02/08/2022
Decision Date 12/16/2022
Decision granted (DENG)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Reclassification Order Reclassification Order
Type Post-NSE
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