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FDA 510(k)

AccelFix Lumbar Plate System

K-Number: K192481 · 2020-07-28

ApplicantL&K BIOMED Co., Ltd.
Decision Date2020-07-28
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AccelFix Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2020-07-28 under 510(k) number K192481. 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 AccelFix Lumbar Plate System?

AccelFix Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2020-07-28. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K192481.

When did AccelFix Lumbar Plate System receive FDA 510(k) clearance?

AccelFix Lumbar Plate System received FDA 510(k) clearance on 2020-07-28, under 510(k) number K192481.

Who is the listed applicant for AccelFix Lumbar Plate System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AccelFix Lumbar Plate System?

The FDA product code for AccelFix Lumbar Plate System is KWQ.

Other records listing L&K BIOMED 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.

K260840BluEX Cervical Expandable Cage SystemK261112CastleLoc-P Anterior Cervical Plate SystemK261130AccelFix Spinal Fixation SystemK260448CastleLoc Pectus Bar SystemK251940PathLoc Lumbar Plate SystemK251741PathLoc Lumbar Interbody Fusion Cage 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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