Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K121302 |
Device Name |
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM |
Applicant |
BIOMET MICROFIXATION |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Applicant Contact |
SHERYL MALMBERG |
Correspondent |
BIOMET MICROFIXATION |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Correspondent Contact |
SHERYL MALMBERG |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 05/01/2012 |
Decision Date | 09/19/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|