FDA 510(k) Application Details - K233592

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K233592
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	BioPoly, LLC 7136 Gettysburg Pike Fort Wayne, IN 46804 US Other 510(k) Applications for this Company
Contact	Herb Schwartz 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	11/08/2023
Decision Date	03/13/2024
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