Device Classification Name |
sacroiliac joint fixation
|
510(k) Number |
K151818 |
Device Name |
SImmetry Sacroiliac Joint Fusion System |
Applicant |
Zyga Technology, Inc. |
5600 Rowland Road, Suite 200 |
Minnetonka,
MN
55343
|
|
Applicant Contact |
Diane Brinza |
Correspondent |
Zyga Technology, Inc. |
5600 Rowland Road, Suite 200 |
Minnetonka,
MN
55343
|
|
Correspondent Contact |
Diane Brinza |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 07/06/2015 |
Decision Date | 08/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|