FDA 510(k) Application Details - K061146

Device Classification Name	Prosthesis, Wrist, Hemi-, Ulnar   More FDA Info for this Device
510(K) Number	K061146
Device Name	Prosthesis, Wrist, Hemi-, Ulnar
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	888.3810   More FDA Info for this Regulation Number
Classification Product Code	KXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2006
Decision Date	07/19/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review