FDA 510(k) Application Details - K192754

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K192754
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
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	888.3170   More FDA Info for this Regulation Number
Classification Product Code	KWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2019
Decision Date	01/07/2020
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