FDA 510(k) Application Details - K222592

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K222592
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant	Encore Medical, L.P 9800 Metric Blvd Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	Michael Siano Other 510(k) Applications for this Contact
Regulation Number	888.3660   More FDA Info for this Regulation Number
Classification Product Code	KWS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2022
Decision Date	06/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review