Device Classification Name |
Sacroiliac Joint Fixation
|
510(k) Number |
K110512 |
Device Name |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Applicant |
Zyga Technology, Inc. |
700 10TH AVENUE SOUTH, |
SUITE 400 |
MINNEAPOLIS,
MN
55415
|
|
Applicant Contact |
Diane Brinza |
Correspondent |
Zyga Technology, Inc. |
700 10TH AVENUE SOUTH, |
SUITE 400 |
MINNEAPOLIS,
MN
55415
|
|
Correspondent Contact |
Diane Brinza |
Regulation Number | 888.3040 |
Classification Product Code |
|
Date Received | 02/23/2011 |
Decision Date | 03/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|