Device Classification Name |
Prosthesis, Elbow, Constrained, Cemented
|
510(k) Number |
K000003 |
Device Name |
TORNIER TOTAL ELBOW PROSTHESIS |
Applicant |
TORNIER |
200 GREGORY LN. |
SUITE C-100 |
PLEASANT HILL,
CA
94523 -3389
|
|
Applicant Contact |
DAVID W SCHLERF |
Correspondent |
TORNIER |
200 GREGORY LN. |
SUITE C-100 |
PLEASANT HILL,
CA
94523 -3389
|
|
Correspondent Contact |
DAVID W SCHLERF |
Regulation Number | 888.3150
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/03/2000 |
Decision Date | 10/02/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|