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FDA 510(k)

ArcadiusXP C Spinal System

K-Number: K153629 · 2016-05-25

ApplicantAesculap Implant Systems, Inc.
Decision Date2016-05-25
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ArcadiusXP C Spinal System is a medical device manufactured by Aesculap Implant Systems, Inc.. It received FDA 510(k) clearance on 2016-05-25 under approval number K153629. 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 ArcadiusXP C Spinal System?

ArcadiusXP C Spinal System is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Aesculap Implant Systems, Inc.. The 510(k) number is K153629.

When was ArcadiusXP C Spinal System approved by the FDA?

ArcadiusXP C Spinal System received FDA 510(k) clearance on 2016-05-25, under approval number K153629.

What company makes ArcadiusXP C Spinal System?

ArcadiusXP C Spinal System is manufactured by Aesculap Implant Systems, Inc..

What is the FDA product code for ArcadiusXP C Spinal System?

The FDA product code for ArcadiusXP C Spinal System is OVE.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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.

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