FDA 510(k) Application Details - K965204

Device Classification Name	Prosthesis, Wrist, Carpal Trapezium   More FDA Info for this Device
510(K) Number	K965204
Device Name	Prosthesis, Wrist, Carpal Trapezium
Applicant	AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	LOUISE M FOCHT 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	12/26/1996
Decision Date	06/03/1997
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review