Device Classification Name |
prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
|
510(k) Number |
K070883 |
Device Name |
DURACON X3 CS TIBIAL INSERT |
Applicant |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
FRANCISCO HARO |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
FRANCISCO HARO |
Regulation Number | 888.3565
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/30/2007 |
Decision Date | 05/11/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|