FDA 510(k) Application Details - K173641

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K173641
Device Name	Plate, Fixation, Bone
Applicant	Newclip Technics PA de la Lande Saint Martin - 45 rue des Garottieres Haute-Goulaine 44 115 FR Other 510(k) Applications for this Company
Contact	Gaelle Lussori 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	11/24/2017
Decision Date	01/16/2018
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