Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K141103 |
Device Name |
INTRAMEDULLARY NAIL AND SCREWS-NEONAIL |
Applicant |
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
11234 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
KEVIN A THOMAS |
Correspondent |
NEOORTHO PRODUTOS ORTOPEDICOS S/A |
11234 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
KEVIN A THOMAS |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 04/29/2014 |
Decision Date | 09/23/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|