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FDA 510(k)

Xenco Medical CancelleX Cervical Interbody System

K-Number: K243673 · 2025-01-29

Decision Date2025-01-29
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenco Medical CancelleX Cervical Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Xenco Medical, LLC. It received FDA 510(k) clearance on 2025-01-29 under 510(k) number K243673. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenco Medical CancelleX Cervical Interbody System?

Xenco Medical CancelleX Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2025-01-29. The listed applicant is Xenco Medical, LLC. The 510(k) number is K243673.

When did Xenco Medical CancelleX Cervical Interbody System receive FDA 510(k) clearance?

Xenco Medical CancelleX Cervical Interbody System received FDA 510(k) clearance on 2025-01-29, under 510(k) number K243673.

Who is the listed applicant for Xenco Medical CancelleX Cervical Interbody System?

The FDA 510(k) record lists Xenco Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Xenco Medical CancelleX Cervical Interbody System?

The FDA product code for Xenco Medical CancelleX Cervical Interbody System is ODP.

Other records listing Xenco Medical, LLC as applicant

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.

View all 11 devices →

Related Devices (Code: ODP)

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.

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.