DeGen Navigated Instrumentation
K-Number: K213918 · 2022-02-09
ApplicantDegen Medical
Decision Date2022-02-09
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 2022-02-09 under approval number K213918. 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 2022-02-09. It is manufactured by Degen Medical. The 510(k) number is K213918.
When was DeGen Navigated Instrumentation approved by the FDA?
DeGen Navigated Instrumentation received FDA 510(k) clearance on 2022-02-09, under approval number K213918.
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
Related Devices (Code: OLO)
K162375Envision 3D: Image Guidance System7D Surgical, Inc.
K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG
K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc.
K160385Precision ScrewCryptych Pty, Ltd.
K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC
K153240Styrker OrthoMap Express Knee SystemStryker Corporate
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.