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FDA 510(k)

Butrex Lumbar Buttress Plating System

K-Number: K170530 · 2017-03-22

ApplicantX-Spine Systems, Inc.
Decision Date2017-03-22
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Butrex Lumbar Buttress Plating System is the device name listed in this FDA 510(k) record. The listed applicant is X-Spine Systems, Inc.. It received FDA 510(k) clearance on 2017-03-22 under 510(k) number K170530. 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 Butrex Lumbar Buttress Plating System?

Butrex Lumbar Buttress Plating System is a medical device that received FDA 510(k) clearance on 2017-03-22. The listed applicant is X-Spine Systems, Inc.. The 510(k) number is K170530.

When did Butrex Lumbar Buttress Plating System receive FDA 510(k) clearance?

Butrex Lumbar Buttress Plating System received FDA 510(k) clearance on 2017-03-22, under 510(k) number K170530.

Who is the listed applicant for Butrex Lumbar Buttress Plating System?

The FDA 510(k) record lists X-Spine Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Butrex Lumbar Buttress Plating System?

The FDA product code for Butrex Lumbar Buttress Plating System is KWQ.

Other records listing X-Spine Systems, Inc. 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.

K173832InTice™-C Porous Ti Cervical Interbody SystemK180153X-spine Cortical Bone Screw SystemK170119Calix Lumbar Spinal Implant SystemK171567IRIX-A Lumbar Integrated Fusion SystemK171075Calix-C Cervical Interbody SpacerK170224Spider Cervical Plating 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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