Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K163543 |
Device Name |
Biomet Fusion System |
Applicant |
Zimmer Biomet Spine Inc. |
310 Interlocken Parkway Suite 120 |
Broomfield,
CO
80021
|
|
Applicant Contact |
Megan Fessenden |
Correspondent |
Zimmer Biomet Spine Inc. |
310 Interlocken Parkway Suite 120 |
Broomfield,
CO
80021
|
|
Correspondent Contact |
Megan Fessenden |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/16/2016 |
Decision Date | 02/28/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|