Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K151178 |
Device Name |
VariAx 2 Wrist Fusion System |
Applicant |
Stryker Trauma AG |
PROF.-KUNTSCHER-STR. 1-5 |
SCHOENKIRCHEN,
DE
24232
|
|
Applicant Contact |
DR. HEIKE GUSTKE |
Correspondent |
Stryker Trauma AG |
PROF.-KUNTSCHER-STR. 1-5 |
SCHOENKIRCHEN,
DE
24232
|
|
Correspondent Contact |
DR. HEIKE GUSTKE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 05/04/2015 |
Decision Date | 06/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|