FDA 510(k) Application Details - K081876

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K081876
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	ALMA RELJA 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	07/02/2008
Decision Date	08/01/2008
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