Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K043404 |
Device Name |
MODIFICATION TO T2 PROXIMAL HUMERAL NAIL |
Applicant |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
VIVIAN KELLY |
Correspondent |
HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
VIVIAN KELLY |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 12/10/2004 |
Decision Date | 12/27/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|