Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
|
510(k) Number |
K010212 |
Device Name |
OFFSET TIBIAL TRAY |
Applicant |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
CAROL LAUSTER |
Correspondent |
BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, |
P.O.BOX 587 |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
CAROL LAUSTER |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 01/23/2001 |
Decision Date | 02/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|