FDA 510(k) Application Details - K061862

Device Classification Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented   More FDA Info for this Device
510(K) Number	K061862
Device Name	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant	AXIOM ORTHOPAEDICS, INC. 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE 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	06/30/2006
Decision Date	08/28/2006
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