FDA 510(k) Application Details - K242782

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K242782
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Noraker 60 Avenue Rockefeller Lyon 69008 FR Other 510(k) Applications for this Company
Contact	Catherine Flacard Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2024
Decision Date	12/23/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review