Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K011237 |
Device Name |
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
DALENE T BINKLEY |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
DALENE T BINKLEY |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/23/2001 |
Decision Date | 05/23/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|