Stansion Matrix

FDA 510(k) K042600 · Spineworks, LLC

Substantially Equivalent

510(k) numberK042600

Submission

Device name
Stansion Matrix
Applicant
Spineworks, LLC
Washington, DC, US
Received
September 23, 2004
Decision date
February 18, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQP – Spinal Vertebral Body Replacement Device
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

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K241468Vertiwedge® Intraosseous SystemMQP · Traditional Foundation Surgical Group, Inc.11/07/2024SE
K232790KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional Icotec AG04/04/2024SE
K233359DOMINION Expandable Corpectomy SystemMQP · Traditional Astura Medical03/08/2024SE
K231134VerteLoc Spinal SystemMQP · Traditional Signature Orthopaedics Pty, Ltd.02/13/2024SE
K232173Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional Alphatec Spine, Inc.10/06/2023SE
K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional Arftx Medical, LLC10/06/2022SE
K202637F3D Corpectomy SystemMQP · Traditional Corelink, LLC12/23/2020SE

More from Corelink, LLC

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K133340Spineworks Anterior Lumbar DeviceMAX · Traditional 04/11/2014SE
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Questions and answers

When was Stansion Matrix cleared by the FDA?

Stansion Matrix (K042600) received a 510(k) decision of Substantially Equivalent on February 18, 2005, 148 days after the submission was received.

What is the product code of K042600?

The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.