Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Intraosseous Fusion Device System

K-Number: K231649 · 2023-09-29

ApplicantAuxano Medical, LLC
Decision Date2023-09-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Intraosseous Fusion Device System is a medical device manufactured by Auxano Medical, LLC. It received FDA 510(k) clearance on 2023-09-29 under approval number K231649. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intraosseous Fusion Device System?

Intraosseous Fusion Device System is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Auxano Medical, LLC. The 510(k) number is K231649.

When was Intraosseous Fusion Device System approved by the FDA?

Intraosseous Fusion Device System received FDA 510(k) clearance on 2023-09-29, under approval number K231649.

What company makes Intraosseous Fusion Device System?

Intraosseous Fusion Device System is manufactured by Auxano Medical, LLC.

What is the FDA product code for Intraosseous Fusion Device System?

The FDA product code for Intraosseous Fusion Device System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07296744 Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) 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: 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 Auxano Medical, LLC

K251791Auxano® Wedge Fixation System

Related Devices (Code: HWC)

K161259KLS Martin Cannulated Headless ScrewsKLS Martin L.P. K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek K161597Tyber Medical BioTy® Nanotopography Trauma ScrewTyber Medical, LLC K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc. K161449HammerTech Fixation SystemFusion Orthopedics, 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.

↑