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FDA 510(k)

Zeus Spinal System

K-Number: K230961 · 2023-10-10

ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2023-10-10
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zeus Spinal System is a medical device manufactured by Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2023-10-10 under approval number K230961. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeus Spinal System?

Zeus Spinal System is a medical device that received FDA 510(k) clearance on 2023-10-10. It is manufactured by Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K230961.

When was Zeus Spinal System approved by the FDA?

Zeus Spinal System received FDA 510(k) clearance on 2023-10-10, under approval number K230961.

What company makes Zeus Spinal System?

Zeus Spinal System is manufactured by Shanghai Sanyou Medical Co, Ltd..

What is the FDA product code for Zeus Spinal System?

The FDA product code for Zeus Spinal System is NKB.

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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)

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Related Devices (Code: NKB)

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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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