FDA 510(k) Application Details - K181262

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K181262
Device Name	Cement, Bone, Vertebroplasty
Applicant	Vexim SA 8 Rue Vidailhan Balma 31130 FR Other 510(k) Applications for this Company
Contact	Vincent Gardes 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	05/11/2018
Decision Date	08/30/2018
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