FDA 510(k) Application Details - K962289

Device Classification Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented   More FDA Info for this Device
510(K) Number	K962289
Device Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant	INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. AUSTIN, TX 78717 US Other 510(k) Applications for this Company
Contact	MITCHELL A DHORITY 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	06/14/1996
Decision Date	08/29/1996
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