FDA 510(k) Application Details - K191811

Device Classification Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K191811
Device Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant	Catalyst OrthoScience, Inc. 14710 Tamiami Trail North, Suite 102 Naples, FL 34110 US Other 510(k) Applications for this Company
Contact	Dale Davison Other 510(k) Applications for this Contact
Regulation Number	888.3650   More FDA Info for this Regulation Number
Classification Product Code	KWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2019
Decision Date	09/11/2019
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