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FDA 510(k)

FortiVy™ OsteoVy™ Lumbar IBF

K-Number: K241783 · 2025-03-18

ApplicantVy Spine, LLC
Decision Date2025-03-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FortiVy™ OsteoVy™ Lumbar IBF is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2025-03-18 under approval number K241783. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FortiVy™ OsteoVy™ Lumbar IBF?

FortiVy™ OsteoVy™ Lumbar IBF is a medical device that received FDA 510(k) clearance on 2025-03-18. It is manufactured by Vy Spine, LLC. The 510(k) number is K241783.

When was FortiVy™ OsteoVy™ Lumbar IBF approved by the FDA?

FortiVy™ OsteoVy™ Lumbar IBF received FDA 510(k) clearance on 2025-03-18, under approval number K241783.

What company makes FortiVy™ OsteoVy™ Lumbar IBF?

FortiVy™ OsteoVy™ Lumbar IBF is manufactured by Vy Spine, LLC.

What is the FDA product code for FortiVy™ OsteoVy™ Lumbar IBF?

The FDA product code for FortiVy™ OsteoVy™ Lumbar IBF is MAX.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.