FDA 510(k)

INNOVERSE Navigation Instruments

K-Number: K241082 · 2024-06-14

Decision Date2024-06-14

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

INNOVERSE Navigation Instruments is a medical device manufactured by Innosys Co., Ltd.. It received FDA 510(k) clearance on 2024-06-14 under approval number K241082. 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 INNOVERSE Navigation Instruments?

INNOVERSE Navigation Instruments is a medical device that received FDA 510(k) clearance on 2024-06-14. It is manufactured by Innosys Co., Ltd.. The 510(k) number is K241082.

When was INNOVERSE Navigation Instruments approved by the FDA?

INNOVERSE Navigation Instruments received FDA 510(k) clearance on 2024-06-14, under approval number K241082.

What company makes INNOVERSE Navigation Instruments?

INNOVERSE Navigation Instruments is manufactured by Innosys Co., Ltd..

What is the FDA product code for INNOVERSE Navigation Instruments?

The FDA product code for INNOVERSE Navigation Instruments is OLO.

Related Clinical Trials

NCT07518615 Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System Falcon RECRUITING

Other Devices by Innosys Co., Ltd.

K231737ANAX 5.5 Spinal System K234119UniSpace® Stand-Alone C Cage K233960INNOVERSE Spinal System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.