Device Classification Name |
Orthopedic Stereotaxic Instrument
|
510(k) Number |
K192133 |
Device Name |
Zimmer Biomet Universal Navigation System |
Applicant |
Zimmer Biomet Spine, Inc. |
10225 Westmoor Dr. |
Westminster,
CO
80021
|
|
Applicant Contact |
Alex Pawlowski |
Correspondent |
Zimmer Biomet Spine, Inc. |
10225 Westmoor Dr. |
Westminster,
CO
80021
|
|
Correspondent Contact |
Alex Pawlowski |
Regulation Number | 882.4560
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/07/2019 |
Decision Date | 10/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|