FDA 510(k) Application Details - K112278

Device Classification Name	Prosthesis, Wrist, Carpal Trapezium   More FDA Info for this Device
510(K) Number	K112278
Device Name	Prosthesis, Wrist, Carpal Trapezium
Applicant	ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 US Other 510(k) Applications for this Company
Contact	BRADLEY W STRASSER Other 510(k) Applications for this Contact
Regulation Number	888.3770   More FDA Info for this Regulation Number
Classification Product Code	KYI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2011
Decision Date	11/04/2011
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