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FDA 510(k)

Spinal Fixation System

K-Number: K190408 · 2020-06-16

ApplicantShangdong Kangsheng Medical Devices Co., Ltd.
Decision Date2020-06-16
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spinal Fixation System is a medical device manufactured by Shangdong Kangsheng Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2020-06-16 under approval number K190408. 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 Spinal Fixation System?

Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-06-16. It is manufactured by Shangdong Kangsheng Medical Devices Co., Ltd.. The 510(k) number is K190408.

When was Spinal Fixation System approved by the FDA?

Spinal Fixation System received FDA 510(k) clearance on 2020-06-16, under approval number K190408.

What company makes Spinal Fixation System?

Spinal Fixation System is manufactured by Shangdong Kangsheng Medical Devices Co., Ltd..

What is the FDA product code for Spinal Fixation System?

The FDA product code for Spinal Fixation System is NKB.

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: NKB)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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