FDA.reportPublic FDA data

510(k) K233241

Device
SOLACE Sacroiliac Fixation System
Applicant
Ht Medical, LLC Dba Xenix Medical
510(k) number
K233241
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-27
Date received
2023-09-28
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
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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510(k), Device, Applicant table
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