FDA 510(k) Application Details - K201831

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K201831
Device Name	Cement, Bone, Vertebroplasty
Applicant	DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767-0350 US Other 510(k) Applications for this Company
Contact	Sergio M. Cordeiro Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	NDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2020
Decision Date	08/31/2020
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