Device Classification Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K033351 |
Device Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
Applicant |
GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC.
5349 RED LEAF COURT
OVIEDO, FL 32765 US
Other 510(k) Applications for this Company
|
Contact |
CARL KNOBLOCH
Other 510(k) Applications for this Contact |
Regulation Number |
888.3530
More FDA Info for this Regulation Number |
Classification Product Code |
HRY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
10/20/2003 |
Decision Date |
03/11/2004 |
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 |
|