FDA 510(k) Application Details - K241873

Device Classification Name	More FDA Info for this Device
510(K) Number	K241873
Device Name	OsseoFit Stemless Shoulder System
Applicant	Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46850 US Other 510(k) Applications for this Company
Contact	Alexandria Irwin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2024
Decision Date	12/11/2024
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