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FDA 510(k)

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

K-Number: K222284 · 2022-10-14

ApplicantApplied Medical Resources Corporation
Decision Date2022-10-14
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is a medical device manufactured by Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2022-10-14 under approval number K222284. 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 Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is a medical device that received FDA 510(k) clearance on 2022-10-14. It is manufactured by Applied Medical Resources Corporation. The 510(k) number is K222284.

When was Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) approved by the FDA?

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) received FDA 510(k) clearance on 2022-10-14, under approval number K222284.

What company makes Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is manufactured by Applied Medical Resources Corporation.

What is the FDA product code for Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)?

The FDA product code for Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) is GEI.

Related Clinical Trials

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Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) 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: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025) 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 Corporation

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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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