Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K201500 |
Device Name |
Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer |
Applicant |
Life Spine Inc. |
13951 S Quality Drive |
Huntley,
IL
60142
|
|
Applicant Contact |
Angela Batker |
Correspondent |
Life Spine Inc. |
13951 S Quality Drive |
Huntley,
IL
60142
|
|
Correspondent Contact |
Angela Batker |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 06/05/2020 |
Decision Date | 08/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|