Device Classification Name |
prosthesis, elbow, semi-constrained, cemented
|
510(k) Number |
K100562 |
Device Name |
LATITUDE ELBOW PROSTHESIS |
Applicant |
TORNIER, INC. |
100 CUMMINGS CENTER |
SUITE 444C |
BEVERLY,
MA
01915
|
|
Applicant Contact |
BRAHIM HADRI |
Correspondent |
TORNIER, INC. |
100 CUMMINGS CENTER |
SUITE 444C |
BEVERLY,
MA
01915
|
|
Correspondent Contact |
BRAHIM HADRI |
Regulation Number | 888.3160
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/01/2010 |
Decision Date | 06/29/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|