FDA.reportPublic FDA data

VerteLP Interbody Fusion Device

Primary DI
B387VLPBALLHEX0
Brand
VerteLP Interbody Fusion Device
Company
VGI MEDICAL, LLC
Model
VLP-BALLHEX
Catalog number
VLPBALLHEX
Device description
VerteLP Angled Implant Inserter Ball-end Hex Driver
Published
2019-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151312000VerteLP Interbody Fusion DeviceVgi, LLC2016-01-13OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B387VLPBALLHEX0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
727-565-1235cs@vgimedical.com

Regulatory Flags#

DUNS number
019936692
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B387VGSJT4216200SiJoin T4 TitaniumVG-SJ-T4-21620VGSJT4216202023-12-12
B387VGSJT4216250SiJoin T4 TitaniumVG-SJ-T4-21625VGSJT4216252023-12-12
B387VGSJT4216300SiJoin T4 TitaniumVG-SJ-T4-21630VGSJT4216302023-12-12
B387VGSJT4216350SiJoin T4 TitaniumVG-SJ-T4-21635VGSJT4216352023-12-12
B387VGSJT4216400SiJoin T4 TitaniumVG-SJ-T4-21640VGSJT4216402023-12-12
B387VGSJT4216500SiJoin T4 TitaniumVG-SJ-T4-21650VGSJT4216502023-12-12
B387VGSJT4222200SiJoin T4 TitaniumVG-SJ-T4-22220VGSJT4222202023-12-12
B387VGSJT4222250SiJoin T4 TitaniumVG-SJ-T4-22225VGSJT4222252023-12-12
B387VGSJT4222300SiJoin T4 TitaniumVG-SJ-T4-22230VGSJT4222302023-12-12
B387VGSJT4222350SiJoin T4 TitaniumVG-SJ-T4-22235VGSJT4222352023-12-12
B387VGSJT4222400SiJoin T4 TitaniumVG-SJ-T4-22240VGSJT4222402023-12-12
B387VGSJT422240750SiJoin T4 TitaniumVG-SJ-T4-2224075VGSJT422240752023-12-12
B387VGSJT4222500SiJoin T4 TitaniumVG-SJ-T4-22250VGSJT4222502023-12-12
B387VGSJT3216200SiJoin T3 TitaniumVG-SJ-T3-21620VGSJT3216202023-06-12
B387VGSJT3216300SiJoin T3 TitaniumVG-SJ-T3-21630VGSJT3216302023-06-12
B387VGSJT3222200SiJoin T3 TitaniumVG-SJ-T3-22220VGSJT3222202023-06-12
B387VGSJT3222400SiJoin T3 TitaniumVG-SJ-T3-22240VGSJT3222402023-06-12
B387VGLP18X40X100VerteLP Interbody Fusion DeviceVG-LP-18x40x10VGLP18X40X102016-09-29
B387VGLP18X40X1070VerteLP Interbody Fusion DeviceVG-LP-18X40X10(7)VGLP18X40X1072016-09-28
B387VGLP18X40X110VerteLP Interbody Fusion DeviceVG-LP-18x40x11VGLP18X40X112016-09-29

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Primary DI, Brand, Company table
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