FDA 510(k) Application Details - K102180

Device Classification Name	Prosthesis, Elbow, Semi-Constrained, Cemented   More FDA Info for this Device
510(K) Number	K102180
Device Name	Prosthesis, Elbow, Semi-Constrained, Cemented
Applicant	SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. MORRISVILLE, PA 19067 US Other 510(k) Applications for this Company
Contact	JAMES O'CONNOR Other 510(k) Applications for this Contact
Regulation Number	888.3160   More FDA Info for this Regulation Number
Classification Product Code	JDB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2010
Decision Date	12/20/2010
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