The following data is part of a premarket notification filed by Sicage Llc with the FDA for Sicage™ System.
| Device ID | K170475 |
| 510k Number | K170475 |
| Device Name: | SICAGE™ System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Sicage LLc 6709 S. Minnesota Ave, Suite 206 Souix Falls, SD 57108 |
| Contact | Kristi Vondra |
| Correspondent | Karen E. Warden, Ph.d. BackRoads Consulting Inc. P.O. Box 566 Chesterland, OH 44026 -0566 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-16 |
| Decision Date | 2017-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M73910110650 | K170475 | 000 |
| M73910110600 | K170475 | 000 |
| M73910110550 | K170475 | 000 |
| M73910110500 | K170475 | 000 |
| M73910110450 | K170475 | 000 |
| M73910110400 | K170475 | 000 |
| M73910110350 | K170475 | 000 |
| M73910110300 | K170475 | 000 |
| M73910110250 | K170475 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SICAGE 87621412 not registered Live/Pending |
Sicage, LLC 2017-09-25 |
![]() SICAGE 86808403 not registered Dead/Abandoned |
Asfora IP, LLC 2015-11-03 |