FDA 510(k) Application Details - K011819

Device Classification Name	Prosthesis, Elbow, Hemi-, Radial, Polymer   More FDA Info for this Device
510(K) Number	K011819
Device Name	Prosthesis, Elbow, Hemi-, Radial, Polymer
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	888.3170   More FDA Info for this Regulation Number
Classification Product Code	KWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2001
Decision Date	06/19/2001
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