| Device Classification Name |
sacroiliac joint fixation
|
|---|
| 510(k) Number |
K150017 |
|---|
| Device Name |
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System |
|---|
| Applicant |
| SpineFrontier, Inc. |
| 500 Cummings Center, Suite 3500 |
|
Beverly,
MA
01915
|
|
| Applicant Contact |
Manthan J Damani |
| Correspondent |
| Empirical Testing Corp. |
| 4628 Northpark Drive |
|
Colorado Springs,
CO
80918
|
|
| Correspondent Contact |
Kenneth C Maxwell |
| Regulation Number | 888.3040
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/05/2015 |
|---|
| Decision Date | 04/24/2015 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Orthopedic
|
|---|
| 510k Review Panel |
Orthopedic
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|