Ostapek VBR System

FDA 510(k) K072326 · Co-Ligne AG

Substantially Equivalent

510(k) numberK072326

Submission

Device name
Ostapek VBR System
Applicant
Co-Ligne AG
Concord, CA, US
Received
August 20, 2007
Decision date
June 24, 2008
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

Other 510(k)s with product code MQP

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K261810Vertiwedge® Intraosseous SystemMQP · Special Foundation Surgical Group07/31/2026SE
K261031Poseidon STMQP · Traditional Signus Medinzintechnik GmbH07/10/2026SE
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

More from Corelink, LLC

510(k)DeviceDecision
K083567Gii Spinal Fixation System, Gii-Ti-Poly Axial ScrewMNH · Special 09/14/2009SE
K051089Gii Spinal Fixation SystemMNH · Traditional 10/26/2005SE
K032604Gii Spinal Fixation SystemMNH · Traditional 01/20/2004SE

Questions and answers

When was Ostapek VBR System cleared by the FDA?

Ostapek VBR System (K072326) received a 510(k) decision of Substantially Equivalent on June 24, 2008, 309 days after the submission was received.

What is the product code of K072326?

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