FDA 510(k) Application Details - K180377

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K180377
Device Name	Screw, Fixation, Bone
Applicant	In2Bones USA, LLC 6060 Poplar Ave, Suite 380 Memphis, TN 38119 US Other 510(k) Applications for this Company
Contact	Rebecca Wahl Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2018
Decision Date	06/20/2018
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