Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K091479 |
Device Name |
APTUS FOOT SYSTEM |
Applicant |
MEDARTIS AG |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
LINDA SCHULZ |
Correspondent |
MEDARTIS AG |
11234 EL CAMINO REAL, STE 200 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LINDA SCHULZ |
Regulation Number | 888.3030 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/19/2009 |
Decision Date | 07/13/2009 |
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
|
Recalls |
CDRH Recalls
|
|
|