Device Classification Name |
Prosthesis, Elbow, Hemi-, Radial, Polymer
More FDA Info for this Device |
510(K) Number |
K994041 |
Device Name |
Prosthesis, Elbow, Hemi-, Radial, Polymer |
Applicant |
TORNIER, INC.
200 GREGORY LN.
SUITE C-100
PLEASANT HILL, CA 94523-3389 US
Other 510(k) Applications for this Company
|
Contact |
DAVID W SCHLERF
Other 510(k) Applications for this Contact |
Regulation Number |
888.3170
More FDA Info for this Regulation Number |
Classification Product Code |
KWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/29/1999 |
Decision Date |
08/31/2000 |
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 |
|