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FDA 510(k)

Voyant® Open Fusion Device (EB240/Open Fusion)

K-Number: K252740 · 2025-11-04

ApplicantApplied Medical Resources Corp.
Decision Date2025-11-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant® Open Fusion Device (EB240/Open Fusion) is a medical device manufactured by Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2025-11-04 under approval number K252740. 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® Open Fusion Device (EB240/Open Fusion)?

Voyant® Open Fusion Device (EB240/Open Fusion) is a medical device that received FDA 510(k) clearance on 2025-11-04. It is manufactured by Applied Medical Resources Corp.. The 510(k) number is K252740.

When was Voyant® Open Fusion Device (EB240/Open Fusion) approved by the FDA?

Voyant® Open Fusion Device (EB240/Open Fusion) received FDA 510(k) clearance on 2025-11-04, under approval number K252740.

What company makes Voyant® Open Fusion Device (EB240/Open Fusion)?

Voyant® Open Fusion Device (EB240/Open Fusion) is manufactured by Applied Medical Resources Corp..

What is the FDA product code for Voyant® Open Fusion Device (EB240/Open Fusion)?

The FDA product code for Voyant® Open Fusion Device (EB240/Open Fusion) 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: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Applied Medical Resources Corp.

K171701GelPOINT Path Transanal Access Platform K182653Voyant Maryland Fusion Device K182244Voyant Electrosurgical Generator K182024Dissecting Balloon System K193292Voyant 5mm Fusion Device, Voyant Maryland Fusion Device K191294Transvaginal Access Platform

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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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