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FDA 510(k)

DeGen Navigated Instrumentation

K-Number: K203816 · 2021-04-02

ApplicantDegen Medical
Decision Date2021-04-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DeGen Navigated Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Degen Medical. It received FDA 510(k) clearance on 2021-04-02 under 510(k) number K203816. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeGen Navigated Instrumentation?

DeGen Navigated Instrumentation is a medical device that received FDA 510(k) clearance on 2021-04-02. The listed applicant is Degen Medical. The 510(k) number is K203816.

When did DeGen Navigated Instrumentation receive FDA 510(k) clearance?

DeGen Navigated Instrumentation received FDA 510(k) clearance on 2021-04-02, under 510(k) number K203816.

Who is the listed applicant for DeGen Navigated Instrumentation?

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

What is the FDA product code for DeGen Navigated Instrumentation?

The FDA product code for DeGen Navigated Instrumentation is OLO.

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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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