FDA 510(k) Application Details - K161114

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K161114
Device Name	Cement, Bone, Vertebroplasty
Applicant	Teknimed, SAS 11, Rue d'Apollo L'Union 31240 FR Other 510(k) Applications for this Company
Contact	J.D. Webb 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	04/20/2016
Decision Date	04/12/2017
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