Device Classification Name |
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
|
510(k) Number |
K080330 |
FOIA Releasable 510(k) |
K080330
|
Device Name |
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3510
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/06/2008 |
Decision Date | 06/11/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|