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FDA 510(k)

Keos Anterior Cervical Interbody Fusion Device System

K-Number: K212450 · 2022-06-06

ApplicantKeos
Decision Date2022-06-06
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Keos Anterior Cervical Interbody Fusion Device System is a medical device manufactured by Keos. It received FDA 510(k) clearance on 2022-06-06 under approval number K212450. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Keos Anterior Cervical Interbody Fusion Device System?

Keos Anterior Cervical Interbody Fusion Device System is a medical device that received FDA 510(k) clearance on 2022-06-06. It is manufactured by Keos. The 510(k) number is K212450.

When was Keos Anterior Cervical Interbody Fusion Device System approved by the FDA?

Keos Anterior Cervical Interbody Fusion Device System received FDA 510(k) clearance on 2022-06-06, under approval number K212450.

What company makes Keos Anterior Cervical Interbody Fusion Device System?

Keos Anterior Cervical Interbody Fusion Device System is manufactured by Keos.

What is the FDA product code for Keos Anterior Cervical Interbody Fusion Device System?

The FDA product code for Keos Anterior Cervical Interbody Fusion Device System is ODP.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Keos

K160631Keos Lumbar IBFD K163386Keos Lumbar IBFD K193174Keos Lumbar IBFD

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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