Device Classification Name |
prosthesis, hip, semi-constrained, composite/metal
|
510(k) Number |
K853259 |
Device Name |
MALLORY/HEAD TOTAL HIP SYSTEM |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
JUDITH DERMUDY |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
JUDITH DERMUDY |
Regulation Number | 888.3340
|
Classification Product Code |
|
Date Received | 08/02/1985 |
Decision Date | 11/01/1985 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|