Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
|
510(k) Number |
K122541 |
Device Name |
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) |
Applicant |
ORTHOFIX SRL |
22423 SKYVIEW DRIVE |
WEST LINN,
OR
97068
|
|
Applicant Contact |
CANDACE F CEDERMAN |
Correspondent |
ORTHOFIX SRL |
22423 SKYVIEW DRIVE |
WEST LINN,
OR
97068
|
|
Correspondent Contact |
CANDACE F CEDERMAN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 08/21/2012 |
Decision Date | 09/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|