Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K963709 |
Device Name |
CEMENT-ON FEMORAL STEM |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Applicant Contact |
KARA L SCHWARTZ |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK |
WARSAW,
IN
46581
|
|
Correspondent Contact |
KARA L SCHWARTZ |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 09/16/1996 |
Decision Date | 12/04/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|