Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K153695 |
Device Name |
Biomet Spine Fusion System |
Applicant |
Biomet Spine LLC. |
310 Interlocken Parkway, Suite 120 |
Broomfield,
CO
80021
|
|
Applicant Contact |
Kyle Hoefling |
Correspondent |
Biomet Spine LLC. |
310 Interlocken Parkway, Suite 120 |
Broomfield,
CO
80021
|
|
Correspondent Contact |
Kyle Hoefling |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 12/23/2015 |
Decision Date | 01/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|