FDA 510(k) Application Details - K251184

Device Classification Name	More FDA Info for this Device
510(K) Number	K251184
Device Name	AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System
Applicant	Encore Medical, L.P. 9800 Metric Boulevard Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	Patricia Kontoudis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2025
Decision Date	05/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review