Device Classification Name |
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
|
510(k) Number |
K071881 |
Device Name |
TRIATHLON PKR SYSTEM |
Applicant |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
VIVIAN KELLY |
Correspondent |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
VIVIAN KELLY |
Regulation Number | 888.3530
|
Classification Product Code |
|
Date Received | 07/09/2007 |
Decision Date | 10/09/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|