Device Classification Name |
appliance, fixation, nail/blade/plate combination, multiple component
|
510(k) Number |
K081244 |
Device Name |
LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS |
Applicant |
BIOMET TRAUMA |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET TRAUMA |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 05/01/2008 |
Decision Date | 07/30/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|