Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K083782 |
Device Name |
REGENEREX PATELLA COMPONENTS |
Applicant |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
SUSAN ALEXANDER |
Correspondent |
BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE |
P.O. BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
SUSAN ALEXANDER |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/2008 |
Decision Date | 04/03/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|