FDA.reportPublic FDA data

VerteLP Interbody Fusion Device

Primary DI
B387VLPINSTRANG0
Brand
VerteLP Interbody Fusion Device
Company
VGI MEDICAL, LLC
Model
VLP-INSTRANG
Catalog number
VLPINSRTANG
Device description
VerteLP Angled Implant Inserter
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
B387VLPINSTRANG0PrimaryHIBCC0

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780640195Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
03700780654611Idys®-ALIF ZP 3DTiCLARIANCEOVD2026-07-28
00643169511651SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511675MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511682MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511712MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511729MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511736MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511774MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511781MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511798MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511804MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511811MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511828MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511873MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511880MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511897MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511903MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511910MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511927MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511934MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511941MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511958MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169511965MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512016MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512030MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512047MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512054SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512061MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19
00643169512078MSB SOVEREIGN™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OVD2026-07-19