FDA 510(k) Application Details - K153395

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K153395
Device Name	Staple, Fixation, Bone
Applicant	IN2BONES SAS 28 CHEMIN DU PETIT BOIS ECULLY 63130 FR Other 510(k) Applications for this Company
Contact	MORGANE GRENIER 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	11/24/2015
Decision Date	02/18/2016
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