FDA 510(k) Application Details - K251556

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K251556
Device Name	Filler, Bone Void, Calcium Compound
Applicant	Geistlich Pharma AG Bahnhofstrasse 40 Wolhusen 6110 CH Other 510(k) Applications for this Company
Contact	Jan Van der Ploeg 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	05/21/2025
Decision Date	07/17/2025
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