Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K153400 |
Device Name |
ProLift Expandable System |
Applicant |
LIFE SPINE, INC. |
13951 S QUALITY DRIVE |
HUNTLEY,
IL
60142
|
|
Applicant Contact |
RANDY LEWIS |
Correspondent |
LIFE SPINE, INC. |
13951 S QUALITY DRIVE |
HUNTLEY,
IL
60142
|
|
Correspondent Contact |
RANDY LEWIS |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 11/24/2015 |
Decision Date | 03/07/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|