FDA 510(k) Application Details - K192449

Device Classification Name	Cement, Bone, Vertebroplasty   More FDA Info for this Device
510(K) Number	K192449
Device Name	Cement, Bone, Vertebroplasty
Applicant	Joline GmbH & Co. KG Neue RottenBurger Strasse 50 Hechingen 72379 DE Other 510(k) Applications for this Company
Contact	Peter Kohlbecher 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	09/06/2019
Decision Date	05/27/2020
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