Spider Cervical Plating System

FDA 510(k) K170224 · X-Spine Systems, Inc.

Substantially Equivalent

510(k) numberK170224

Submission

Device name
Spider Cervical Plating System
Applicant
X-Spine Systems, Inc.
Miamisburg, OH, US
Received
January 25, 2017
Decision date
July 6, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWQ – Appliance, Fixation, Spinal Intervertebral Body
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWQ

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K261309Palisades™ Buttress Plate SystemKWQ · Traditional Bethesda Medical Devices, LLC07/16/2026SE
K252776ARIES Anterior Cervical Plate SystemsKWQ · Traditional ZheJiang Decans Medical Devices Co., Ltd.05/14/2026SE
K261112CastleLoc-P Anterior Cervical Plate SystemKWQ · Special L&K BIOMED Co., Ltd.05/06/2026SE
K260570corra™ cervical plating systemKWQ · Traditional Carlsmed, Inc.04/22/2026SE
K260697VyPlate™ Anterior Cervical Plate SystemKWQ · Special Vy Spine, LLC03/27/2026SE
K260015ANTERIS Thoracolumbar Plate SystemKWQ · Traditional SpineCraft03/04/2026SE
K251940PathLoc Lumbar Plate SystemKWQ · Traditional L&K BIOMED Co., Ltd.03/03/2026SE
K254182AsterKWQ · Traditional Osteonic Co., Ltd.02/26/2026SE
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special 4Web, Inc.02/12/2026SE
K252611aprevo® cervical plating systemKWQ · Traditional Carlsmed, Inc.12/22/2025SE

More from Carlsmed, Inc.

510(k)DeviceDecision
K173832InTice™-C Porous Ti Cervical Interbody SystemODP · Traditional 05/17/2018SE
K180153X-spine Cortical Bone Screw SystemNKB · Traditional 03/15/2018SE
K170119Calix Lumbar Spinal Implant SystemMAX · Traditional 09/29/2017SE
K171567IRIX-A Lumbar Integrated Fusion SystemOVD · Traditional 08/28/2017SE
K171075Calix-C Cervical Interbody SpacerODP · Traditional 08/01/2017SE
K170530Butrex Lumbar Buttress Plating SystemKWQ · Special 03/22/2017SE
K160959Xsert Lumbar Expandable Interbody SystemMAX · Traditional 11/17/2016SE
K162944Irix-C Cervical Integrated Fusion SystemOVE · Traditional 11/07/2016SE
K160428Certex Spinal Fixation SystemNKG · Traditional 05/05/2016SE
K160114Xspan Laminoplasty Fixation SystemNQW · Traditional 03/15/2016SE

Questions and answers

When was Spider Cervical Plating System cleared by the FDA?

Spider Cervical Plating System (K170224) received a 510(k) decision of Substantially Equivalent on July 6, 2017, 162 days after the submission was received.

What is the product code of K170224?

The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.