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FDA 510(k)

CoLink Sfx Implant System

K-Number: K203698 · 2021-05-04

ApplicantIn2bones USA, LLC
Decision Date2021-05-04
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CoLink Sfx Implant System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2021-05-04 under 510(k) number K203698. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoLink Sfx Implant System?

CoLink Sfx Implant System is a medical device that received FDA 510(k) clearance on 2021-05-04. The listed applicant is In2bones USA, LLC. The 510(k) number is K203698.

When did CoLink Sfx Implant System receive FDA 510(k) clearance?

CoLink Sfx Implant System received FDA 510(k) clearance on 2021-05-04, under 510(k) number K203698.

Who is the listed applicant for CoLink Sfx Implant System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink Sfx Implant System?

The FDA product code for CoLink Sfx Implant System is HTY.

Other records listing In2bones USA, LLC as applicant

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Related Devices (Code: HTY)

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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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