FDA.reportPublic FDA data

VerteGlide Spinal Growth Guidance System

Primary DI
00840194480093
Brand
VerteGlide Spinal Growth Guidance System
Company
ORTHOPEDIATRICS CORP.
Model
01-1720-5500
Catalog number
01-1720-5500
Device description
VERTEGLIDE 5.5MM CANNULATED TAP
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241816000VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.2025-03-14PGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194480093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194480093008401944800938401944800930840194480093

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132177570OrthoPediatrics QuickPack Bone Void FillerOPQS1005OPQS10052020-02-11
00841132177587OrthoPediatrics QuickPack Bone Void FillerOPQS1008OPQS10082020-02-11
00841132177594OrthoPediatrics QuickPack Bone Void FillerOPQS1016OPQS10162020-02-11
00841132177600OrthoPediatrics QuickPack Bone Void FillerOPQS0004OPQS00042020-02-11
00840536824288PediHipNS-5001-1711NS-5001-17112026-10-07
00840536824295PediHipNS-5001-1712NS-5001-17122026-10-07
00840536824301PediHipNS-5001-1713NS-5001-17132026-10-07
00840536824318PediHipNS-5001-1714NS-5001-17142026-10-07
00840536824325PediHipNS-5001-1715NS-5001-17152026-10-07
00840536824332PediHipNS-5001-1716NS-5001-17162026-10-07
00840536824349PediHipNS-5001-1721NS-5001-17212026-10-07
00840536824356PediHipNS-5001-1722NS-5001-17222026-10-07
00840536824363PediHipNS-5001-1723NS-5001-17232026-10-07
00840536824370PediHipNS-5001-1724NS-5001-17242026-10-07
00840536824387PediHipNS-5001-1725NS-5001-17252026-10-07
00840536824394PediHipNS-5001-1726NS-5001-17262026-10-07
00817867021044PNP Femur00-1560-716000-1560-71602026-10-01
00817867021051PNP Femur00-1560-716500-1560-71652026-10-01
00817867021068PNP Femur00-1560-717000-1560-71702026-10-01
00817867021075PNP Femur00-1560-717500-1560-71752026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713390ROSA® ShoulderOrthosoft IncOLO2026-10-15
00885556919781Real IntelligenceSmith & Nephew, Inc.OLO2026-10-13
10705034648194VELYSMedos International SàrlOLO2026-10-09
10705034648200VELYSMedos International SàrlOLO2026-10-09
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
00810055525225Onyx 4.5 mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525232Onyx 5.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525249Onyx 6.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525256Onyx 7.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
00810055525263Onyx 4.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525270Onyx 5.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525720Onyx Navigated Locking DriverSi-Bone Inc.OLO2026-09-30
00810055525966Onyx Navigated Locking Driver, CannulatedSi-Bone Inc.OLO2026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mmSi-Bone Inc.OLO2026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mmSi-Bone Inc.OLO2026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mmSi-Bone Inc.OLO2026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mmSi-Bone Inc.OLO2026-09-30
00810055526321Onyx iGPS DriverSi-Bone Inc.OLO2026-09-30
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
04056481146702Curve NavigationBrainlab SEOLO2025-10-13
07613327631814RPSStryker Leibinger GmbH & Co. KGOLO2025-10-03
04056481146054Patient Reference Rod-Clamp Spine & TraumaBrainlab SEOLO2025-09-19