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FDA 510(k)

Voyant Open Fusion Device

K-Number: K162676 · 2016-12-01

Decision Date2016-12-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant Open Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 2016-12-01 under 510(k) number K162676. 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?

Voyant Open Fusion Device is a medical device that received FDA 510(k) clearance on 2016-12-01. The listed applicant is Applied Medical Resources. The 510(k) number is K162676.

When did Voyant Open Fusion Device receive FDA 510(k) clearance?

Voyant Open Fusion Device received FDA 510(k) clearance on 2016-12-01, under 510(k) number K162676.

Who is the listed applicant for Voyant Open Fusion Device?

The FDA 510(k) record lists Applied Medical Resources as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant Open Fusion Device?

The FDA product code for Voyant Open Fusion Device is GEI.

Other records listing Applied Medical Resources as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 28 devices →

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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