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FDA 510(k)

CoreLink Midline Fixation System

K-Number: K210539 · 2021-04-15

ApplicantCorelink, LLC
Decision Date2021-04-15
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoreLink Midline Fixation System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2021-04-15 under approval number K210539. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoreLink Midline Fixation System?

CoreLink Midline Fixation System is a medical device that received FDA 510(k) clearance on 2021-04-15. It is manufactured by Corelink, LLC. The 510(k) number is K210539.

When was CoreLink Midline Fixation System approved by the FDA?

CoreLink Midline Fixation System received FDA 510(k) clearance on 2021-04-15, under approval number K210539.

What company makes CoreLink Midline Fixation System?

CoreLink Midline Fixation System is manufactured by Corelink, LLC.

What is the FDA product code for CoreLink Midline Fixation System?

The FDA product code for CoreLink Midline Fixation System is NKB.

Related Clinical Trials

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Other Devices by Corelink, LLC

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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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