Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
510(k) Number |
K122210 |
Device Name |
NEWFIX EXTERNAL FIXATION SYSTEM |
Applicant |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
PO BOX 506 |
SOUTH LYON,
MI
48178
|
|
Applicant Contact |
ROBERT J BARD |
Correspondent |
TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V |
PO BOX 506 |
SOUTH LYON,
MI
48178
|
|
Correspondent Contact |
ROBERT J BARD |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 04/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|