Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K192021 |
Device Name |
NCB Polyaxial Locking Plate System |
Applicant |
Zimmer GmbH |
Sulzerallee 8 |
Winterthur,
CH
8404
|
|
Applicant Contact |
Annemie Rehor Kausch |
Correspondent |
Zimmer GmbH |
Sulzerallee 8 |
Winterthur,
CH
8404
|
|
Correspondent Contact |
Danielle Jannuzzi Madureira |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/29/2019 |
Decision Date | 08/22/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|