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FDA 510(k)

DeGen Medical Latitude-C AM Cervical Interbody Fusion System

K-Number: K252737 · 2025-10-10

ApplicantDegen Medical
Decision Date2025-10-10
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DeGen Medical Latitude-C AM Cervical Interbody Fusion System is a medical device manufactured by Degen Medical. It received FDA 510(k) clearance on 2025-10-10 under approval number K252737. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeGen Medical Latitude-C AM Cervical Interbody Fusion System?

DeGen Medical Latitude-C AM Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Degen Medical. The 510(k) number is K252737.

When was DeGen Medical Latitude-C AM Cervical Interbody Fusion System approved by the FDA?

DeGen Medical Latitude-C AM Cervical Interbody Fusion System received FDA 510(k) clearance on 2025-10-10, under approval number K252737.

What company makes DeGen Medical Latitude-C AM Cervical Interbody Fusion System?

DeGen Medical Latitude-C AM Cervical Interbody Fusion System is manufactured by Degen Medical.

What is the FDA product code for DeGen Medical Latitude-C AM Cervical Interbody Fusion System?

The FDA product code for DeGen Medical Latitude-C AM Cervical Interbody Fusion System is ODP.

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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.