| Device Classification Name |
Pin, Fixation, Smooth
|
| 510(k) Number |
K102072 |
| Device Name |
MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) |
| Applicant |
| Memometal Technologies |
| Rue Blaise Pascal |
| Campus De Ker Lann |
|
Bruz,
FR
35170
|
|
| Applicant Contact |
GILLES AUDIC |
| Correspondent |
| Memometal Technologies |
| Rue Blaise Pascal |
| Campus De Ker Lann |
|
Bruz,
FR
35170
|
|
| Correspondent Contact |
GILLES AUDIC |
| Regulation Number | 888.3040 |
| Classification Product Code |
|
| Date Received | 07/23/2010 |
| Decision Date | 11/03/2010 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|