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FDA 510(k)

SOLACE Sacroiliac Fixation System

K-Number: K233241 · 2023-10-27

ApplicantHt Medical, LLC Dba Xenix Medical
Decision Date2023-10-27
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLACE Sacroiliac Fixation System is a medical device manufactured by Ht Medical, LLC Dba Xenix Medical. It received FDA 510(k) clearance on 2023-10-27 under approval number K233241. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLACE Sacroiliac Fixation System?

SOLACE Sacroiliac Fixation System is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Ht Medical, LLC Dba Xenix Medical. The 510(k) number is K233241.

When was SOLACE Sacroiliac Fixation System approved by the FDA?

SOLACE Sacroiliac Fixation System received FDA 510(k) clearance on 2023-10-27, under approval number K233241.

What company makes SOLACE Sacroiliac Fixation System?

SOLACE Sacroiliac Fixation System is manufactured by Ht Medical, LLC Dba Xenix Medical.

What is the FDA product code for SOLACE Sacroiliac Fixation System?

The FDA product code for SOLACE Sacroiliac Fixation System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT05367505 Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis RECRUITING

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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