FDA 510(k) Application Details - K203698

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K203698
Device Name	Pin, Fixation, Smooth
Applicant	In2Bones USA, LLC 6000 Poplar Ave, Suite 115 Memphis, TN 38119 US Other 510(k) Applications for this Company
Contact	Christine Scifert Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2020
Decision Date	05/04/2021
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