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

FDA 510(k)

The Entasis Dual-Lead Sacroiliac Implant

K-Number: K152237 · 2016-02-04

ApplicantCorelink, LLC
Decision Date2016-02-04
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Entasis Dual-Lead Sacroiliac Implant is the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K152237. 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 The Entasis Dual-Lead Sacroiliac Implant?

The Entasis Dual-Lead Sacroiliac Implant is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Corelink, LLC. The 510(k) number is K152237.

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

The Entasis Dual-Lead Sacroiliac Implant received FDA 510(k) clearance on 2016-02-04, under 510(k) number K152237.

Who is the listed applicant for The Entasis Dual-Lead Sacroiliac Implant?

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 The Entasis Dual-Lead Sacroiliac Implant?

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

Related Clinical Trials

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.

NCT07763431Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant ProsthesesNOT_YET_RECRUITING

Other records listing Corelink, LLC as applicant

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.

K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate SystemK231494CoreLink Robotic Navigation InstrumentsK232116CoreLink Navigation InstrumentsK230329F3D Interbody SystemK230880CoreLink Navigation InstrumentsK223708Entasis 3D Dual-Lead Sacroiliac Implant System

View all 23 devices →

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.

↑