FDA 510(k) Application Details - K183094

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K183094
Device Name	Washer, Bolt Nut
Applicant	Cycla Orthopedics Ltd 14 Hame Yasdim st. Bat shlomo 30992 IL Other 510(k) Applications for this Company
Contact	Rafi Herzog Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2018
Decision Date	04/26/2019
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