FDA 510(k)

Entasis 3D Dual-Lead Sacroiliac Implant System

K-Number: K223708 · 2023-03-21

Decision Date2023-03-21

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Entasis 3D Dual-Lead Sacroiliac Implant System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2023-03-21 under approval number K223708. 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 Entasis 3D Dual-Lead Sacroiliac Implant System?

Entasis 3D Dual-Lead Sacroiliac Implant System is a medical device that received FDA 510(k) clearance on 2023-03-21. It is manufactured by Corelink, LLC. The 510(k) number is K223708.

When was Entasis 3D Dual-Lead Sacroiliac Implant System approved by the FDA?

Entasis 3D Dual-Lead Sacroiliac Implant System received FDA 510(k) clearance on 2023-03-21, under approval number K223708.

What company makes Entasis 3D Dual-Lead Sacroiliac Implant System?

Entasis 3D Dual-Lead Sacroiliac Implant System is manufactured by Corelink, LLC.

What is the FDA product code for Entasis 3D Dual-Lead Sacroiliac Implant System?

The FDA product code for Entasis 3D Dual-Lead Sacroiliac Implant System is OUR.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Corelink, LLC

K152237The Entasis Dual-Lead Sacroiliac Implant K163104Terrace Anterior Cervical Plate System K162496Foundation 3D Interbody K183239CoreLink F3D Lateral System K180814CoreLink® M3 Stand-Alone Anterior Lumbar System K180556Corelink Foundation 3D Anterior Lumbar System

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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.