FDA 510(k) Application Details - K231188

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K231188
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	Skeletal Dynamics Inc 7300 North Kendall Drive Miami, FL 33156 US Other 510(k) Applications for this Company
Contact	Alexandra Rodriguez Rojas 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	04/26/2023
Decision Date	09/28/2023
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