FDA 510(k) Application Details - K243826

Device Classification Name	More FDA Info for this Device
510(K) Number	K243826
Device Name	SMR Reverse HP Shoulder System
Applicant	LimaCorporate S.p.A. Via Nazionale, 52 33038 Villanova di San Daniele del Friuli Udine IT Other 510(k) Applications for this Company
Contact	Marco Tallerico 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	12/12/2024
Decision Date	07/03/2025
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