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510(k) K233241

SOLACE Sacroiliac Fixation System by Ht Medical, LLC Dba Xenix Medical — Product Code OUR

K233241 is an FDA 510(k) premarket notification submitted by Ht Medical, LLC Dba Xenix Medical for the device "SOLACE Sacroiliac Fixation System". The FDA issued a decision of Substantially Equivalent on October 27, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2023
Date Received
September 28, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

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FDA data resources