FDA 510(k) Application Details - K234105

Device Classification Name	More FDA Info for this Device
510(K) Number	K234105
Device Name	Catalyst F1x Shoulder System
Applicant	Catalyst OrthoScience, Inc. 14710 Tamiami Trail, North Ste. 102 Naples, FL 34110 US Other 510(k) Applications for this Company
Contact	Dale Davison 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	12/26/2023
Decision Date	04/05/2024
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