Anterior Buttress Plate

FDA 510(k) K081548 · Scient'X USA, Inc.

Substantially Equivalent

510(k) numberK081548

Submission

Device name
Anterior Buttress Plate
Applicant
Scient'X USA, Inc.
Maitland, FL, US
Received
June 2, 2008
Decision date
January 29, 2009
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
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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
K080588Scient'X Tribeca VBRMAX · Traditional 05/30/2008SE
K053292Davantis/Antelys Vertebral Body ReplacementsMQP · Special 01/19/2006SE
K031290Modification to Easys Transverse ConnectionMNH · Special 05/13/2003SE

Questions and answers

When was Anterior Buttress Plate cleared by the FDA?

Anterior Buttress Plate (K081548) received a 510(k) decision of Substantially Equivalent on January 29, 2009, 241 days after the submission was received.

What is the product code of K081548?

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