Device Classification Name |
prosthesis, shoulder, semi-constrained, metal/polymer cemented
|
510(k) Number |
K160555 |
Device Name |
BLUEPRINT Patient Specific Instrumentation |
Applicant |
TORNIER SAS |
161 RUE LAVOISIER |
MONTBONNOT SAINT MARTIN,
FR
38330
|
|
Applicant Contact |
AYMEN AZAIEZ |
Correspondent |
TORNIER SAS |
161 RUE LAVOISIER |
MONTBONNOT SAINT MARTIN,
FR
38330
|
|
Correspondent Contact |
AYMEN AZAIEZ |
Regulation Number | 888.3660
|
Classification Product Code |
|
Date Received | 02/29/2016 |
Decision Date | 06/10/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|