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FDA 510(k)

Entasis 3D Dual-Lead Sacroiliac Implant System

K-Number: K223708 · 2023-03-21

ApplicantCorelink, LLC
Decision Date2023-03-21
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Entasis 3D Dual-Lead Sacroiliac Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2023-03-21 under 510(k) 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. The listed applicant is Corelink, LLC. The 510(k) number is K223708.

When did Entasis 3D Dual-Lead Sacroiliac Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for Entasis 3D Dual-Lead Sacroiliac Implant System?

The FDA 510(k) record lists Corelink, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Corelink, LLC as applicant

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Related Devices (Code: OUR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

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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