Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K110574 |
Device Name |
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM |
Applicant |
BIOMET MICROFIXATION, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Applicant Contact |
SHERYL MALMBERG |
Correspondent |
BIOMET MICROFIXATION, INC. |
1520 TRADEPORT DR. |
JACKSONVILLE,
FL
32218
|
|
Correspondent Contact |
SHERYL MALMBERG |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 03/01/2011 |
Decision Date | 05/18/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|