FDA 510(k) Application Details - K012377

Device Classification Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented   More FDA Info for this Device
510(K) Number	K012377
Device Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant	CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 TAMPA, FL 33612 US Other 510(k) Applications for this Company
Contact	JOEL BATTS Other 510(k) Applications for this Contact
Regulation Number	888.3690   More FDA Info for this Regulation Number
Classification Product Code	HSD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2001
Decision Date	03/11/2002
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