Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K033233 |
Device Name |
LACTOSORB TIBIAL L-15 SCREW AND WASHER |
Applicant |
BIOMET, INC. |
56 BELL DR. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA SANDBORN BERES |
Correspondent |
BIOMET, INC. |
56 BELL DR. |
PO BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA SANDBORN BERES |
Regulation Number | 888.3040 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/06/2003 |
Decision Date | 11/05/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|