Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
More FDA Info for this Device |
510(K) Number |
K954053 |
Device Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite |
Applicant |
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN, TX 78759 US
Other 510(k) Applications for this Company
|
Contact |
J D WEBB
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 |
08/29/1995 |
Decision Date |
05/16/1996 |
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 |
|