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FDA 510(k)

MVP Cervical Plate System

K-Number: K190170 · 2019-05-13

ApplicantGS Medical Co., Ltd.
Decision Date2019-05-13
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MVP Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-05-13 under 510(k) number K190170. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MVP Cervical Plate System?

MVP Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-05-13. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K190170.

When did MVP Cervical Plate System receive FDA 510(k) clearance?

MVP Cervical Plate System received FDA 510(k) clearance on 2019-05-13, under 510(k) number K190170.

Who is the listed applicant for MVP Cervical Plate System?

The FDA 510(k) record lists GS Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MVP Cervical Plate System?

The FDA product code for MVP Cervical Plate System is KWQ.

Other records listing GS Medical Co., Ltd. as applicant

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.

K243073AnyPlus Navigated Instruments SystemK241738PYXIS 3D Titanium Cervical Cage systemK240350AnyPlus II Spinal Fixation SystemK231808QUASAR Standalone ACIF SystemK223868PYXIS 3D Titanium Cage SystemK222041CYGNUS-C Standalone ACIF System

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Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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