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
|