FDA 510(k) Application Details - K213287

Device Classification Name	Bone Cement, Antibiotic   More FDA Info for this Device
510(K) Number	K213287
Device Name	Bone Cement, Antibiotic
Applicant	Biomet, Inc. 56 East Bell Drive Warsaw, IN 46581 US Other 510(k) Applications for this Company
Contact	Anuja Yardi Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	MBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2021
Decision Date	09/02/2022
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