FDA 510(k) Application Details - K080997

Device Classification Name	Prosthesis, Wrist, Carpal Lunate   More FDA Info for this Device
510(K) Number	K080997
Device Name	Prosthesis, Wrist, Carpal Lunate
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	888.3750   More FDA Info for this Regulation Number
Classification Product Code	KWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/08/2008
Decision Date	06/17/2008
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