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FDA 510(k)

EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM

K-Number: K090415 · 2009-06-01

ApplicantEminent Spine
Decision Date2009-06-01
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eminent Spine. It received FDA 510(k) clearance on 2009-06-01 under 510(k) number K090415. 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 EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM?

EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-06-01. The listed applicant is Eminent Spine. The 510(k) number is K090415.

When did EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM receive FDA 510(k) clearance?

EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM received FDA 510(k) clearance on 2009-06-01, under 510(k) number K090415.

Who is the listed applicant for EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM?

The FDA 510(k) record lists Eminent Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM?

The FDA product code for EMINENT SPINE BUTTRESS (FANG) PLATE SYSTEM is KWQ.

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Other records listing Eminent Spine 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.

K250894Eminent Spine Posterior SI SystemK241663Eminent Spine 3D Titanium Pedicle Screw SystemK242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemK212701Eminent Spine 3D Cervical Interbody Fusion SystemK221936Standalone ALIF Interbody Fusion SystemK103068KING COBRA ANTERIOR CERVICAL PLATE

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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.

K262149corra® cervical plating systemCarlsmed, Inc.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, LLC

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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