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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 the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2025-11-12 under 510(k) 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. The listed applicant is Icotec AG. The 510(k) number is K252327.

When did CMORE® CT System; CMORE® CT System Navigated Instruments receive FDA 510(k) clearance?

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

Who is the listed applicant for CMORE® CT System; CMORE® CT System Navigated Instruments?

The FDA 510(k) record lists Icotec AG as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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