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FDA 510(k)

CoreLink Navigation Instruments

K-Number: K212825 · 2021-10-13

ApplicantCorelink, LLC
Decision Date2021-10-13
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CoreLink Navigation Instruments is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2021-10-13 under approval number K212825. 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 Navigation Instruments?

CoreLink Navigation Instruments is a medical device that received FDA 510(k) clearance on 2021-10-13. It is manufactured by Corelink, LLC. The 510(k) number is K212825.

When was CoreLink Navigation Instruments approved by the FDA?

CoreLink Navigation Instruments received FDA 510(k) clearance on 2021-10-13, under approval number K212825.

What company makes CoreLink Navigation Instruments?

CoreLink Navigation Instruments is manufactured by Corelink, LLC.

What is the FDA product code for CoreLink Navigation Instruments?

The FDA product code for CoreLink Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

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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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