Device Classification Name |
prosthesis, knee, femorotibial, constrained, cemented, metal/polymer
|
510(k) Number |
K945028 |
Device Name |
FINN KNEE SYSTEM |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3510
|
Classification Product Code |
|
Date Received | 10/13/1994 |
Decision Date | 02/14/1996 |
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
|
|
|