Device Classification Name |
intervertebral fusion device with bone graft, lumbar
|
510(k) Number |
K192497 |
Device Name |
EVOL ha - D Lateral Interbody Fusion System |
Applicant |
Cutting Edge Spine, LLC |
101 Waxhaw Professional Park, Suite A |
Waxhaw,
NC
28173
|
|
Applicant Contact |
Kyle Kuntz |
Correspondent |
Cutting Edge Spine, LLC |
101 Waxhaw Professional Park, Suite A |
Waxhaw,
NC
28173
|
|
Correspondent Contact |
Kyle Kuntz |
Regulation Number | 888.3080
|
Classification Product Code |
|
Date Received | 09/11/2019 |
Decision Date | 01/06/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|