Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K993111 |
Device Name |
ASCENT KNEE SYSTEM |
Applicant |
BIOMET MANUFACTURING, INC. |
AIRPORT INDUSTRIAL PARK |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
MARY VERSTYNEN |
Correspondent |
BIOMET MANUFACTURING, INC. |
AIRPORT INDUSTRIAL PARK |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
MARY VERSTYNEN |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 09/17/1999 |
Decision Date | 10/05/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|