FDA 510(k) Application Details - K220131

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K220131
Device Name	Cement, Bone, Vertebroplasty
Applicant	Tecres S.p.A. via Andrea Doria 6 Sommacampagna 37066 IT Other 510(k) Applications for this Company
Contact	Massio Grazioli 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	01/18/2022
Decision Date	04/18/2022
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