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FDA 510(k)

CoLink® Mini Plating System

K-Number: K191535 · 2019-07-29

ApplicantIn2bones USA, LLC
Decision Date2019-07-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoLink® Mini Plating System is a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2019-07-29 under approval number K191535. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoLink® Mini Plating System?

CoLink® Mini Plating System is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by In2bones USA, LLC. The 510(k) number is K191535.

When was CoLink® Mini Plating System approved by the FDA?

CoLink® Mini Plating System received FDA 510(k) clearance on 2019-07-29, under approval number K191535.

What company makes CoLink® Mini Plating System?

CoLink® Mini Plating System is manufactured by In2bones USA, LLC.

What is the FDA product code for CoLink® Mini Plating System?

The FDA product code for CoLink® Mini Plating System is HRS.

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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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