FDA 510(k) Application Details - K231657

Device Classification Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K231657
Device Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant	Implantcast, GmbH Luneburger Schanze 26 Buxtehude 21614 DE Other 510(k) Applications for this Company
Contact	Juliane H÷ppner Other 510(k) Applications for this Contact
Regulation Number	888.3650   More FDA Info for this Regulation Number
Classification Product Code	KWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2023
Decision Date	02/16/2024
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