Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device |
510(K) Number |
K042059 |
Device Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
Applicant |
HAND INNOVATIONS, INC.
8905 SW 87TH AVENUE
SUITE 220
MIAMI, FL 33176 US
Other 510(k) Applications for this Company
|
Contact |
AL WEISENBORN
Other 510(k) Applications for this Contact |
Regulation Number |
888.3030
More FDA Info for this Regulation Number |
Classification Product Code |
LXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/30/2004 |
Decision Date |
09/30/2004 |
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 |
|