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 |
|