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FDA 510(k)

CoLink NeoFuse MIS Plating System (see attached parts list)

K-Number: K241387 · 2024-08-13

ApplicantIn2bones USA
Decision Date2024-08-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoLink NeoFuse MIS Plating System (see attached parts list) is a medical device manufactured by In2bones USA. It received FDA 510(k) clearance on 2024-08-13 under approval number K241387. 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 NeoFuse MIS Plating System (see attached parts list)?

CoLink NeoFuse MIS Plating System (see attached parts list) is a medical device that received FDA 510(k) clearance on 2024-08-13. It is manufactured by In2bones USA. The 510(k) number is K241387.

When was CoLink NeoFuse MIS Plating System (see attached parts list) approved by the FDA?

CoLink NeoFuse MIS Plating System (see attached parts list) received FDA 510(k) clearance on 2024-08-13, under approval number K241387.

What company makes CoLink NeoFuse MIS Plating System (see attached parts list)?

CoLink NeoFuse MIS Plating System (see attached parts list) is manufactured by In2bones USA.

What is the FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list)?

The FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list) 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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