Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K943025 |
Device Name |
FREEMAN/SAMUELSON TOTAL KNEE SYSTEM |
Applicant |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
PATRICIA S BERES |
Correspondent |
BIOMET, INC. |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
PATRICIA S BERES |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 06/27/1994 |
Decision Date | 03/13/1996 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|