FDA.reportPublic FDA data

VerteGlide Spinal Growth Guidance System

Primary DI
00840194479981
Brand
VerteGlide Spinal Growth Guidance System
Company
ORTHOPEDIATRICS CORP.
Model
01-1723-1500
Catalog number
01-1723-1500
Device description
VERTEGLIDE 5.5mm MANUAL COUNTER TORQUE TUBE
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
PGMGrowing rod system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGMGrowing Rod SystemOrthopedic2

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
00840194479981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194479981008401944799818401944799810840194479981

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. 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
00840536822741Response 5.5/6.001-1300-653501-1300-65352026-05-30
00840536822758Response 5.5/6.001-1300-653601-1300-65362026-05-30
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000874308SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-05-07
00763000874315SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-05-07
08720629951256SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951287SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951300SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951324SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951478SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951485SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951492SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629951508SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958750SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958767SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958774SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
08720629958828SDS Growing RodBaat Medical Products B.V.PGM2026-03-30
00763000874070SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-02-21
00763000874339SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2026-02-12
00763000874568SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-20
00613994796158SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796738SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796769SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796776SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796783SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994796837SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00613994805638SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-11-14
00763000874742SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000874827SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000875213SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000875237SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-05
00763000874445SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-04
00763000875183SHILLA™ Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.PGM2025-10-03