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FDA 510(k)

Voyant Fine Fusion Device (EB230)

K-Number: K202818 · 2021-12-16

ApplicantApplied Medical
Decision Date2021-12-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant Fine Fusion Device (EB230) is a medical device manufactured by Applied Medical. It received FDA 510(k) clearance on 2021-12-16 under approval number K202818. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voyant Fine Fusion Device (EB230)?

Voyant Fine Fusion Device (EB230) is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Applied Medical. The 510(k) number is K202818.

When was Voyant Fine Fusion Device (EB230) approved by the FDA?

Voyant Fine Fusion Device (EB230) received FDA 510(k) clearance on 2021-12-16, under approval number K202818.

What company makes Voyant Fine Fusion Device (EB230)?

Voyant Fine Fusion Device (EB230) is manufactured by Applied Medical.

What is the FDA product code for Voyant Fine Fusion Device (EB230)?

The FDA product code for Voyant Fine Fusion Device (EB230) is GEI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024)

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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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