Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K181096 |
Device Name |
Avenue P Cage System |
Applicant |
Zimmer Biomet Spine, Inc. |
10225 Westmoor Drive |
Westminster,
CO
80021
|
|
Applicant Contact |
Alex Pawlowski |
Correspondent |
Zimmer Biomet Spine, Inc. |
10225 Westmoor Drive |
Westminster,
CO
80021
|
|
Correspondent Contact |
Alex Pawlowski |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/26/2018 |
Decision Date | 01/15/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|