Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K142419 |
Device Name |
Mini and Micro Fragments Reconstruction System-NEOFIX |
Applicant |
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
RUA ANGELO DOMINGOS DURIGAN, 607, CASCATINHA |
CURITIBA,
BR
82025-100
|
|
Applicant Contact |
Mariana de Oliveira Quinzani |
Correspondent |
PAXMED INTERNATIONAL, LLC |
12264 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
Kevin A Thomas |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/28/2014 |
Decision Date | 12/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|