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FDA 510(k)

Adena-Zina Spinal System

K-Number: K231931 · 2023-07-28

ApplicantShanghai Sanyou Medical Co, Ltd.
Decision Date2023-07-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Adena-Zina Spinal System is a medical device manufactured by Shanghai Sanyou Medical Co, Ltd.. It received FDA 510(k) clearance on 2023-07-28 under approval number K231931. 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 Adena-Zina Spinal System?

Adena-Zina Spinal System is a medical device that received FDA 510(k) clearance on 2023-07-28. It is manufactured by Shanghai Sanyou Medical Co, Ltd.. The 510(k) number is K231931.

When was Adena-Zina Spinal System approved by the FDA?

Adena-Zina Spinal System received FDA 510(k) clearance on 2023-07-28, under approval number K231931.

What company makes Adena-Zina Spinal System?

Adena-Zina Spinal System is manufactured by Shanghai Sanyou Medical Co, Ltd..

What is the FDA product code for Adena-Zina Spinal System?

The FDA product code for Adena-Zina 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)

Other Devices by Shanghai Sanyou Medical Co, Ltd.

K152781Adena-Zina System K163366Shanghai Sanyou CARMEN Cervical Fusion System K163422Shanghai Sanyou PEEK Cage System K211689KEYSTONE PEEK Cage System K212066Adena-Zina System K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System

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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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