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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 s.a.s.
161 rue lavoisier
montbonnot-saint-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
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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