FDA 510(k)

SpineNet SSP System

K-Number: K200170 · 2020-02-05

Decision Date2020-02-05

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SpineNet SSP System is the device name listed in this FDA 510(k) record. The listed applicant is Spinenet, LLC. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K200170. 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 SpineNet SSP System?

SpineNet SSP System is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Spinenet, LLC. The 510(k) number is K200170.

When did SpineNet SSP System receive FDA 510(k) clearance?

SpineNet SSP System received FDA 510(k) clearance on 2020-02-05, under 510(k) number K200170.

Who is the listed applicant for SpineNet SSP System?

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

What is the FDA product code for SpineNet SSP System?

The FDA product code for SpineNet SSP System is KWQ.

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, LLC K252776ARIES 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 K260015ANTERIS Thoracolumbar Plate SystemSpineCraft

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.