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FDA 510(k)

KeYi Spinal Fixation System

K-Number: K190567 · 2019-05-08

ApplicantBeijing Keyi Medical Device Technology Co., Ltd.
Decision Date2019-05-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KeYi Spinal Fixation System is a medical device manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-08 under approval number K190567. 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 KeYi Spinal Fixation System?

KeYi Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2019-05-08. It is manufactured by Beijing Keyi Medical Device Technology Co., Ltd.. The 510(k) number is K190567.

When was KeYi Spinal Fixation System approved by the FDA?

KeYi Spinal Fixation System received FDA 510(k) clearance on 2019-05-08, under approval number K190567.

What company makes KeYi Spinal Fixation System?

KeYi Spinal Fixation System is manufactured by Beijing Keyi Medical Device Technology Co., Ltd..

What is the FDA product code for KeYi Spinal Fixation System?

The FDA product code for KeYi Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

Other Devices by Beijing Keyi Medical Device Technology Co., Ltd.

K162380Locking Plate System K191826KeYi Total Hip System K230120KeYi Total Knee System

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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