FDA 510(k) Application Details - K060536

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K060536
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	OSTEOMED L.P. 3885 ARAPAHO RD. ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	DAWN T HOLDEMAN Other 510(k) Applications for this Contact
Regulation Number	888.3730   More FDA Info for this Regulation Number
Classification Product Code	KWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2006
Decision Date	06/02/2006
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