Blustone Synergy Silica System

FDA 510(k) K172330 · Blustone Synergy

Substantially Equivalent

510(k) numberK172330

Submission

Device name
Blustone Synergy Silica System
Applicant
Blustone Synergy
Pueblo, CO, US
Received
August 2, 2017
Decision date
December 21, 2017
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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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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K210382Blustone Synergy Diamond SA Cervical SystemOVE · Traditional 07/23/2021SE
K203520Blustone Synergy Interbody Fusion SystemODP · Traditional 04/07/2021SE

Questions and answers

When was Blustone Synergy Silica System cleared by the FDA?

Blustone Synergy Silica System (K172330) received a 510(k) decision of Substantially Equivalent on December 21, 2017, 141 days after the submission was received.

What is the product code of K172330?

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