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FDA 510(k)

CoreLink Robotic Navigation Instruments

K-Number: K231494 · 2023-10-27

ApplicantCorelink, LLC
Decision Date2023-10-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CoreLink Robotic Navigation Instruments is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2023-10-27 under approval number K231494. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoreLink Robotic Navigation Instruments?

CoreLink Robotic Navigation Instruments is a medical device that received FDA 510(k) clearance on 2023-10-27. It is manufactured by Corelink, LLC. The 510(k) number is K231494.

When was CoreLink Robotic Navigation Instruments approved by the FDA?

CoreLink Robotic Navigation Instruments received FDA 510(k) clearance on 2023-10-27, under approval number K231494.

What company makes CoreLink Robotic Navigation Instruments?

CoreLink Robotic Navigation Instruments is manufactured by Corelink, LLC.

What is the FDA product code for CoreLink Robotic Navigation Instruments?

The FDA product code for CoreLink Robotic Navigation Instruments is OLO.

Related Clinical Trials

NCT07574762 Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery RECRUITING NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING NCT06308120 A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis to ENB ACTIVE_NOT_RECRUITING NCT05980442 Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty RECRUITING NCT06962436 RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNs RECRUITING

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: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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