Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
|
510(k) Number |
K030055 |
Device Name |
MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS |
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 | 888.3358
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/06/2003 |
Decision Date | 08/11/2003 |
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
|
|
|