VERTICALE® Navigation Instruments
K-Number: K223649 · 2022-12-22
ApplicantSilony Medical GmbH
Decision Date2022-12-22
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
VERTICALE® Navigation Instruments is a medical device manufactured by Silony Medical GmbH. It received FDA 510(k) clearance on 2022-12-22 under approval number K223649. 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 VERTICALE® Navigation Instruments?
VERTICALE® Navigation Instruments is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Silony Medical GmbH. The 510(k) number is K223649.
When was VERTICALE® Navigation Instruments approved by the FDA?
VERTICALE® Navigation Instruments received FDA 510(k) clearance on 2022-12-22, under approval number K223649.
What company makes VERTICALE® Navigation Instruments?
VERTICALE® Navigation Instruments is manufactured by Silony Medical GmbH.
What is the FDA product code for VERTICALE® Navigation Instruments?
The FDA product code for VERTICALE® Navigation Instruments is OLO.
Related Clinical Trials
Other Devices by Silony Medical GmbH
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.