Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K162507 |
Device Name |
Arzzt 3.5 / 4.5 Small & Large Fragments System |
Applicant |
TRUEMED GROUP, LLC |
20507 NANNETTE LN |
SPRINT,
TX
77388
|
|
Applicant Contact |
Jorge Castillo |
Correspondent |
Registrar Corp |
144 Research Drive |
Hampton,
VA
23666
|
|
Correspondent Contact |
Lara Luzak |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/08/2016 |
Decision Date | 08/03/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|