FDA 510(k) Application Details - K033242

Device Classification Name	Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)   More FDA Info for this Device
510(K) Number	K033242
Device Name	Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Applicant	IMAGING THERAPEUTICS, INC. 1720 SOUTH AMPHLETT BLVD. SUITE 240 SAN MATEO, CA 94402 US Other 510(k) Applications for this Company
Contact	LYNDALL ERB Other 510(k) Applications for this Contact
Regulation Number	888.3590   More FDA Info for this Regulation Number
Classification Product Code	HSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/2003
Decision Date	12/31/2003
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