Device Classification Name |
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
|
510(k) Number |
K033769 |
FOIA Releasable 510(k) |
K033769
|
Device Name |
EIUS UNICOMPARTMENTAL KNEE SYSTEM |
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 | 888.3520
|
Classification Product Code |
|
Date Received | 12/03/2003 |
Decision Date | 02/13/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|