Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K062498 |
Device Name |
PROFYLE SYSTEM |
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 | 888.3030
|
Classification Product Code |
|
Date Received | 08/25/2006 |
Decision Date | 10/25/2006 |
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
|
|
|