FDA.reportPublic FDA data

510(k) K231134

Device
VerteLoc Spinal System
Applicant
Signature Orthopaedics Pty, Ltd.
510(k) number
K231134
Product code
MQP
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-13
Date received
2023-04-21
Regulation
888.3060
Classification name
Spinal Vertebral Body Replacement Device
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Declan Brazil
Address
7 Sirius Rd. Lane Cove West AU 2066 2066

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K202637F3D Corpectomy SystemCorelink, LLC2020-12-23
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K192117Small VBR™Ulrich GmbH & Co. KG2019-11-01
K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.2019-10-24
K192214CarboClear VBR SystemCarboFix Orthopedics , Ltd.2019-10-11
K183054SYNMESH SystemDepuy Synthes Spine2019-05-23