Stgc-Lordotic

FDA 510(k) K142030 · Cardinal Spine, LLC

Substantially Equivalent

510(k) numberK142030

Submission

Device name
Stgc-Lordotic
Applicant
Cardinal Spine, LLC
San Diego, CA, US
Received
July 25, 2014
Decision date
January 23, 2015
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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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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K152568C-VbrPLR · Traditional 02/11/2016SE
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Questions and answers

When was Stgc-Lordotic cleared by the FDA?

Stgc-Lordotic (K142030) received a 510(k) decision of Substantially Equivalent on January 23, 2015, 182 days after the submission was received.

What is the product code of K142030?

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