Device Classification Name |
sacroiliac joint fixation
|
510(k) Number |
K162733 |
Device Name |
iFuse Implant System® - iFuse-3D implant |
Applicant |
SI-BONE, INC. |
3055 OLIN AVE, SUITE 2200 |
SAN JOSE,
CA
95128
|
|
Applicant Contact |
ROXANNE DUBOIS |
Correspondent |
SI-BONE, INC. |
3055 OLIN AVE, SUITE 2200 |
SAN JOSE,
CA
95128
|
|
Correspondent Contact |
ROXANNE DUBOIS |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/29/2016 |
Decision Date | 03/10/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|