VADER® Pedicle System Navigated Instruments
K-Number: K230861 · 2023-06-27
ApplicantIcotec AG
Decision Date2023-06-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
VADER® Pedicle System Navigated Instruments is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2023-06-27 under approval number K230861. 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 VADER® Pedicle System Navigated Instruments?
VADER® Pedicle System Navigated Instruments is a medical device that received FDA 510(k) clearance on 2023-06-27. It is manufactured by Icotec AG. The 510(k) number is K230861.
When was VADER® Pedicle System Navigated Instruments approved by the FDA?
VADER® Pedicle System Navigated Instruments received FDA 510(k) clearance on 2023-06-27, under approval number K230861.
What company makes VADER® Pedicle System Navigated Instruments?
VADER® Pedicle System Navigated Instruments is manufactured by Icotec AG.
What is the FDA product code for VADER® Pedicle System Navigated Instruments?
The FDA product code for VADER® Pedicle System Navigated Instruments 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.