Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K041466 |
Device Name |
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) |
Applicant |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
WARSAW,
IN
46582
|
|
Applicant Contact |
TRACY J BICKEL, RAC |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
WARSAW,
IN
46582
|
|
Correspondent Contact |
TRACY J BICKEL, RAC |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 06/02/2004 |
Decision Date | 07/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|