Device Classification Name |
sacroiliac joint fixation
|
510(k) Number |
K130092 |
Device Name |
SIMMETRY SACROILIAC JOINT FUSION SYSTEM |
Applicant |
Zyga Technology, Inc. |
700 10TH AVE SOUTH, STE 20 |
MINNEAPOLIS,
MN
55415 -1745
|
|
Applicant Contact |
Diane Brinza |
Correspondent |
Zyga Technology, Inc. |
700 10TH AVE SOUTH, STE 20 |
MINNEAPOLIS,
MN
55415 -1745
|
|
Correspondent Contact |
Diane Brinza |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 01/15/2013 |
Decision Date | 02/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|