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FDA 510(k)

YAHUA Spinal System

K-Number: K152324 · 2016-02-01

ApplicantBeijing Weigao Yahua Artificial Joint Development Co. , Ltd.
Decision Date2016-02-01
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

YAHUA Spinal System is a medical device manufactured by Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.. It received FDA 510(k) clearance on 2016-02-01 under approval number K152324. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YAHUA Spinal System?

YAHUA Spinal System is a medical device that received FDA 510(k) clearance on 2016-02-01. It is manufactured by Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.. The 510(k) number is K152324.

When was YAHUA Spinal System approved by the FDA?

YAHUA Spinal System received FDA 510(k) clearance on 2016-02-01, under approval number K152324.

What company makes YAHUA Spinal System?

YAHUA Spinal System is manufactured by Beijing Weigao Yahua Artificial Joint Development Co. , Ltd..

What is the FDA product code for YAHUA Spinal System?

The FDA product code for YAHUA Spinal System is MNI.

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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)

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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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