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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 a medical device manufactured by Degen Medical. It received FDA 510(k) clearance on 2021-04-02 under approval 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. It is manufactured by Degen Medical. The 510(k) number is K203816.

When was DeGen Navigated Instrumentation approved by the FDA?

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

What company makes DeGen Navigated Instrumentation?

DeGen Navigated Instrumentation is manufactured by Degen Medical.

What is the FDA product code for DeGen Navigated Instrumentation?

The FDA product code for DeGen Navigated Instrumentation is OLO.

Other Devices by Degen Medical

K160926F1 MPS Modular Pedicle Screw System K173814DeGen Medical E3 MIS Pedicle Screw System K201287Impulse Interbody Fusion System K210090Impulse AM Interbody Fusion System K213918DeGen Navigated Instrumentation K213901Cyclops™ Anterior Cervical Plate System

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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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