FDA 510(k) Application Details - K191636

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K191636
Device Name	Staple, Fixation, Bone
Applicant	Medartis AG Hochbergerstrasse 60E Basel CH-4057 CH Other 510(k) Applications for this Company
Contact	Andrea Schweizer Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2019
Decision Date	08/16/2019
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