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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 the device name listed in this FDA 510(k) record. The listed applicant is Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) 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. The listed applicant is Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.. The 510(k) number is K152324.

When did YAHUA Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for YAHUA Spinal System?

The FDA 510(k) record lists Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YAHUA Spinal System?

The FDA product code for YAHUA Spinal System is MNI.

Related Devices (Code: MNI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.

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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