FDA 510(k) Application Details - K092047

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K092047
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 AUSTIN, TX 78754-3832 US Other 510(k) Applications for this Company
Contact	DEBBIE STEARNS 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	07/06/2009
Decision Date	01/14/2010
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