Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Xenco Medical Posterior Cervical System

K-Number: K161478 · 2016-09-06

Decision Date2016-09-06
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Xenco Medical Posterior Cervical System is a medical device manufactured by Xenco Medical, LLC. It received FDA 510(k) clearance on 2016-09-06 under approval number K161478. 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 Xenco Medical Posterior Cervical System?

Xenco Medical Posterior Cervical System is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Xenco Medical, LLC. The 510(k) number is K161478.

When was Xenco Medical Posterior Cervical System approved by the FDA?

Xenco Medical Posterior Cervical System received FDA 510(k) clearance on 2016-09-06, under approval number K161478.

What company makes Xenco Medical Posterior Cervical System?

Xenco Medical Posterior Cervical System is manufactured by Xenco Medical, LLC.

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

The FDA product code for Xenco Medical Posterior Cervical System is NKG.

Related Clinical Trials

Related PubMed Literature

Other Devices by Xenco Medical, LLC

View all 11 devices →

Related Devices (Code: NKG)

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.