Anterior Cervical Plate System

FDA 510(k) K151553 · Osteomed Implantes, Ltda

Substantially Equivalent

510(k) numberK151553

Submission

Device name
Anterior Cervical Plate System
Applicant
Osteomed Implantes, Ltda
Rio Claro - Sp, BR
Received
June 9, 2015
Decision date
February 10, 2016
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
K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…ODP · Traditional 06/10/2015SE
K150294DPZ Pedicular Fixation SystemMNI · Traditional 06/05/2015SE

Questions and answers

When was Anterior Cervical Plate System cleared by the FDA?

Anterior Cervical Plate System (K151553) received a 510(k) decision of Substantially Equivalent on February 10, 2016, 246 days after the submission was received.

What is the product code of K151553?

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