FDA 510(k) Application Details - K062898

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K062898
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
Applicant	SMALL BONE INNOVATIONS INC. 505 PARK AVE., 14TH FLOOR NEW YORK, NY 10022 US Other 510(k) Applications for this Company
Contact	ROBERT HOEHN Other 510(k) Applications for this Contact
Regulation Number	888.3170   More FDA Info for this Regulation Number
Classification Product Code	KWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2006
Decision Date	11/13/2006
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