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FDA 510(k)

Xenix Medical Sacroiliac Fixation System

K-Number: K231829 · 2023-08-15

ApplicantHt Medical D.B.A. Xenix Medical
Decision Date2023-08-15
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenix Medical Sacroiliac Fixation System is a medical device manufactured by Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2023-08-15 under approval number K231829. 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 Xenix Medical Sacroiliac Fixation System?

Xenix Medical Sacroiliac Fixation System is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by Ht Medical D.B.A. Xenix Medical. The 510(k) number is K231829.

When was Xenix Medical Sacroiliac Fixation System approved by the FDA?

Xenix Medical Sacroiliac Fixation System received FDA 510(k) clearance on 2023-08-15, under approval number K231829.

What company makes Xenix Medical Sacroiliac Fixation System?

Xenix Medical Sacroiliac Fixation System is manufactured by Ht Medical D.B.A. Xenix Medical.

What is the FDA product code for Xenix Medical Sacroiliac Fixation System?

The FDA product code for Xenix Medical Sacroiliac Fixation System is OUR.

Related Clinical Trials

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Ht Medical D.B.A. Xenix Medical

K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

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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