Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K142906 |
Device Name |
APTUS Wrist 2.5 System |
Applicant |
MEDARTIS AG |
HOCHBERGERSTRASSE 60E |
BASEL,
CH
CH-4057
|
|
Applicant Contact |
Andrea Schweizer |
Correspondent |
PAXMED INTERNATIONAL, LLC |
12264 EL CAMINO REAL |
SUITE 400 |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
Kevin A Thomas |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/06/2014 |
Decision Date | 06/09/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|