Device Classification Name |
sacroiliac joint fixation
|
510(k) Number |
K170475 |
Device Name |
SICAGE™ System |
Applicant |
Sicage LLc |
6709 S. Minnesota Ave, Suite 206 |
Souix Falls,
SD
57108
|
|
Applicant Contact |
Kristi Vondra |
Correspondent |
BackRoads Consulting Inc. |
P.O. Box 566 |
Chesterland,
OH
44026 -0566
|
|
Correspondent Contact |
Karen E. Warden, Ph.D. |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/16/2017 |
Decision Date | 05/05/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|