Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
|
510(k) Number |
K032418 |
Device Name |
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING |
Applicant |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Applicant Contact |
DENISE DUCHENE |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH |
ALLENDALE,
NJ
07401 -1677
|
|
Correspondent Contact |
DENISE DUCHENE |
Regulation Number | 888.3565
|
Classification Product Code |
|
Date Received | 08/05/2003 |
Decision Date | 09/11/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|