Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K181827 |
Device Name |
Affixus Natural Nail System Humeral Nail |
Applicant |
Zimmer GmbH |
Sulzerallee 8 |
Winterthur,
CH
8404
|
|
Applicant Contact |
Robert Tommasini |
Correspondent |
Zimmer GmbH |
Sulzerallee 8 |
Winterthur,
CH
8404
|
|
Correspondent Contact |
Danielle Jannuzzi Madureira |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 07/09/2018 |
Decision Date | 12/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|