The following data is part of a premarket notification filed by Si-technology, Llc with the FDA for Si-technology® Si-desis® Screws.
| Device ID | K151462 |
| 510k Number | K151462 |
| Device Name: | SI-TECHNOLOGY® SI-DESIS® SCREWS |
| Classification | Sacroiliac Joint Fixation |
| Applicant | SI-TECHNOLOGY, LLC 320 EAST VINE DRIVE, SUITE 217 Fort Collins, CO 80524 |
| Contact | Chris Donner |
| Correspondent | Linda Braddon SECURE BIOMED EVALUATIONS 7828 HICKORY FLAT HIGHWAY SUITE 120 Woodstock, GA 30188 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-01 |
| Decision Date | 2015-08-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SI-TECHNOLOGY 85247772 4731719 Live/Registered |
JCBD, LLC 2011-02-21 |