Device Classification Name |
prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
|
510(k) Number |
K042883 |
Device Name |
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT |
Applicant |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Applicant Contact |
DENISE DUCHENE |
Correspondent |
HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. |
MAHWAH,
NJ
07430
|
|
Correspondent Contact |
DENISE DUCHENE |
Regulation Number | 888.3560
|
Classification Product Code |
|
Date Received | 10/19/2004 |
Decision Date | 11/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|