Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K133460 |
Device Name |
APTUS CANNULATED COMPRESSION SCREWS |
Applicant |
MEDARTIS AG |
12264 EL CAMINO REAL, STE 400 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
ALLISON KOMIYAMA |
Correspondent |
MEDARTIS AG |
12264 EL CAMINO REAL, STE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
ALLISON KOMIYAMA |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/12/2013 |
Decision Date | 12/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|