Device Classification Name |
shoulder prosthesis, reverse configuration
|
510(k) Number |
K232265 |
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 |
|
Subsequent Product Codes |
|
Date Received | 07/31/2023 |
Decision Date | 02/21/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|