Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K120449 |
Device Name |
HEALIX ADVANCE PEEK ANCHOR |
Applicant |
Depuy Mitek |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Applicant Contact |
YAYOI FUJIMAKI |
Correspondent |
Depuy Mitek |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
YAYOI FUJIMAKI |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/14/2012 |
Decision Date | 05/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|