SYNMESH System

FDA 510(k) K183054 · Depuy Synthes Spine

Substantially Equivalent

510(k) numberK183054

Submission

Device name
SYNMESH System
Applicant
Depuy Synthes Spine
Raynham, MA, US
Received
November 2, 2018
Decision date
May 23, 2019
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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K253158VyBrate™ VBR SystemMQP · Traditional Vy Spine, LLC01/07/2026SE
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

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Questions and answers

When was SYNMESH System cleared by the FDA?

SYNMESH System (K183054) received a 510(k) decision of Substantially Equivalent on May 23, 2019, 202 days after the submission was received.

What is the product code of K183054?

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