DeGen Navigated Instrumentation

Orthopedic Stereotaxic Instrument

DeGen Medical

The following data is part of a premarket notification filed by Degen Medical with the FDA for Degen Navigated Instrumentation.

Pre-market Notification Details

Device IDK203816
510k NumberK203816
Device Name:DeGen Navigated Instrumentation
ClassificationOrthopedic Stereotaxic Instrument
Applicant DeGen Medical 1321-C North Cashua Drive Florence,  SC  29501
ContactCraig Black
CorrespondentLinda Braddon
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-29
Decision Date2021-04-02

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