Sec VBR

FDA 510(k) K091743 · Innvotec Surgical, Inc.

Substantially Equivalent

510(k) numberK091743

Submission

Device name
Sec VBR
Applicant
Innvotec Surgical, Inc.
Washington, DC, US
Received
June 16, 2009
Decision date
November 2, 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
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
K093669Sec Ibf CageMAX · Traditional 03/18/2010SE

Questions and answers

When was Sec VBR cleared by the FDA?

Sec VBR (K091743) received a 510(k) decision of Substantially Equivalent on November 2, 2009, 139 days after the submission was received.

What is the product code of K091743?

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