FDA 510(k) Application Details - DEN220012

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN220012
Device Name	Tornier Pyrocarbon Humeral Head
Applicant	Tornier SAS 161 Rue Lavoisier Montbonnot St. Martin 38330 FR Other 510(k) Applications for this Company
Contact	Loucinda Bjorklund Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/08/2022
Decision Date	12/16/2022
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review