FDA 510(k) Application Details - K170401

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K170401
Device Name	Plate, Fixation, Bone
Applicant	CarboFix Orthopedics Ltd. 11 Ha'hoshlim St. Herzeliya 4672411 IL Other 510(k) Applications for this Company
Contact	Yael Rubin Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2017
Decision Date	05/12/2017
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