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 |