Device Classification Name |
Sacroiliac Joint Fixation
|
510(k) Number |
K190025 |
Device Name |
EVOL® -SI Joint 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 Drive, Suite A |
Waxhaw,
NC
28173
|
|
Correspondent Contact |
Kyle Kuntz |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 01/07/2019 |
Decision Date | 08/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|