FDA.report

510(k) K251525

Device
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
Applicant
Si-Technology, LLC
510(k) number
K251525
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-06
Date received
2025-05-19
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Chris Donner
Address
320 E. Vine Dr., Suite 217 Fort Collins CO US 80524 80524

FDA Registration Numbers

Source Documents

510(k) summary PDF

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