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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 a medical device manufactured by In2bones USA, LLC. It received FDA 510(k) clearance on 2021-05-04 under approval 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. It is manufactured by In2bones USA, LLC. The 510(k) number is K203698.

When was CoLink Sfx Implant System approved by the FDA?

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

What company makes CoLink Sfx Implant System?

CoLink Sfx Implant System is manufactured by In2bones USA, LLC.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by In2bones USA, LLC

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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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