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FDA 510(k)

CMORE® CT System; CMORE® CT System Navigated Instruments

K-Number: K252327 · 2025-11-12

ApplicantIcotec AG
Decision Date2025-11-12
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CMORE® CT System; CMORE® CT System Navigated Instruments is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2025-11-12 under approval number K252327. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMORE® CT System; CMORE® CT System Navigated Instruments?

CMORE® CT System; CMORE® CT System Navigated Instruments is a medical device that received FDA 510(k) clearance on 2025-11-12. It is manufactured by Icotec AG. The 510(k) number is K252327.

When was CMORE® CT System; CMORE® CT System Navigated Instruments approved by the FDA?

CMORE® CT System; CMORE® CT System Navigated Instruments received FDA 510(k) clearance on 2025-11-12, under approval number K252327.

What company makes CMORE® CT System; CMORE® CT System Navigated Instruments?

CMORE® CT System; CMORE® CT System Navigated Instruments is manufactured by Icotec AG.

What is the FDA product code for CMORE® CT System; CMORE® CT System Navigated Instruments?

The FDA product code for CMORE® CT System; CMORE® CT System Navigated Instruments is NKG.

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Related PubMed Literature

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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.

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