Device Classification Name |
prosthesis, elbow, hemi-, radial, polymer
|
510(k) Number |
K012551 |
Device Name |
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE |
Applicant |
BIOMET, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA SANDBORN BERES |
Correspondent |
BIOMET, INC. |
56 EAST BELL DR. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA SANDBORN BERES |
Regulation Number | 888.3170
|
Classification Product Code |
|
Date Received | 08/07/2001 |
Decision Date | 01/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|