FDA.reportPublic FDA data

510(k) K231829

Device
Xenix Medical Sacroiliac Fixation System
Applicant
Ht Medical D.B.A. Xenix Medical
510(k) number
K231829
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-15
Date received
2023-06-21
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Teresa Cherry
Address
111 W. Jefferson St. Suite 100 Orlando FL US 32801 32801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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