Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K122415 |
Device Name |
X-FIX DYNAMIC EXTERNAL DISTRACTOR |
Applicant |
AREX USA LLC |
1709 HILL ST. |
EDGEWATER,
FL
32132
|
|
Applicant Contact |
CHARLES HOKANSON |
Correspondent |
AREX USA LLC |
1709 HILL ST. |
EDGEWATER,
FL
32132
|
|
Correspondent Contact |
CHARLES HOKANSON |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 08/08/2012 |
Decision Date | 03/15/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|