Xenco Medical Cervical Interbody System
K-Number: K160313 · 2016-10-21
ApplicantXenco Medical, LLC
Decision Date2016-10-21
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Xenco Medical Cervical Interbody System is a medical device manufactured by Xenco Medical, LLC. It received FDA 510(k) clearance on 2016-10-21 under approval number K160313. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xenco Medical Cervical Interbody System?
Xenco Medical Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Xenco Medical, LLC. The 510(k) number is K160313.
When was Xenco Medical Cervical Interbody System approved by the FDA?
Xenco Medical Cervical Interbody System received FDA 510(k) clearance on 2016-10-21, under approval number K160313.
What company makes Xenco Medical Cervical Interbody System?
Xenco Medical Cervical Interbody System is manufactured by Xenco Medical, LLC.
What is the FDA product code for Xenco Medical Cervical Interbody System?
The FDA product code for Xenco Medical Cervical Interbody System is OVE.
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Other Devices by Xenco Medical, LLC
Related Devices (Code: OVE)
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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.