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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sacroiliac Joint Fixation
510(k) Number K233241
Device Name SOLACE Sacroiliac Fixation System
Applicant
Ht Medical, LLC Dba Xenix Medical
111 W. Jefferson St.
Suite 100
Orlando,  FL  32801
Applicant Contact Teresa Cherry
Correspondent
Ht Medical, LLC Dba Xenix Medical
111 W. Jefferson St.
Suite 100
Orlando,  FL  32801
Correspondent Contact Teresa Cherry
Regulation Number888.3040
Classification Product Code
OUR  
Subsequent Product Codes
HWC   OLO  
Date Received09/28/2023
Decision Date 10/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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