Device Classification Name |
prosthesis, ankle, semi-constrained, cemented, metal/polymer
|
510(k) Number |
K090076 |
Device Name |
SALTO TALARIS TOTAL ANKLE PROSTHESIS |
Applicant |
TORNIER |
161 RUE LAVOISIER |
MONTBONNOT |
SAINT-ISMIER CEDEX,
FR
38334
|
|
Applicant Contact |
SEVERINE BONNETON |
Correspondent |
TORNIER |
161 RUE LAVOISIER |
MONTBONNOT |
SAINT-ISMIER CEDEX,
FR
38334
|
|
Correspondent Contact |
SEVERINE BONNETON |
Regulation Number | 888.3110
|
Classification Product Code |
|
Date Received | 01/12/2009 |
Decision Date | 03/17/2009 |
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
|
|
|