VerteGlide Spinal Growth Guidance System 00-1721-6530

GUDID 00840194463409

VERTEGLIDE 4.5 POLYAXIAL PEDICLE SCREW 6.5MM X 30MM, OPEN

ORTHOPEDIATRICS CORP.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840194463409
• NIH Device Record Key: 834fbce7-71b6-4acd-95a1-3e3fac87580b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VerteGlide Spinal Growth Guidance System
• Version Model Number: 00-1721-6530
• Catalog Number: 00-1721-6530
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194463409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241816

FDA Product Code

• PGM: Growing rod system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

On-Brand Devices [VerteGlide Spinal Growth Guidance System]

• 00841132191019: VERTEGLIDE IMPLANT CADDY LID
• 00841132191002: VERTEGLIDE PIN MAT TRAY
• 00841132184745: VERTEGLIDE LID
• 00841132179178: VERTEGLIDE BASE
• 00840194493864: VERTEGLIDE UNIVERSAL INSTRUMENTS TRAY 2 (TOP)
• 00840194493857: VERTEGLIDE UNIVERSAL INSTRUMENTS TRAY 1 (BOTTOM)
• 00840194493833: VERTEGLIDE 5.5MM IMPLANT CADDY
• 00840194493826: VERTEGLIDE 5.5MM IMPLANTS/INSTRUMENTS TRAY
• 00840194493802: VERTEGLIDE 4.5MM IMPLANT CADDY
• 00840194493796: VERTEGLIDE 4.5MM IMPLANTS/INSTRUMENTS TRAY
• 00840194480222: VERTEGLIDE PROVISIONAL SET SCREW DRIVER
• 00840194480215: 5.5MM PROVISIONAL ROD
• 00840194480208: VERTEGLIDE 5.5MM ROD BEND CHECKER
• 00840194480192: NAVIGATED ROUND AWL
• 00840194480178: SOFT BEND FRENCH BENDER
• 00840194480161: ROD TEMPLATE
• 00840194480154: GUIDE WIRE
• 00840194480147: COUNTER TORQUE HANDLE
• 00840194480130: NAVIGATED CANNULATED LENKE PROBE - INSERT
• 00840194480123: NAVIGATED CANNULATED LENKE PROBE
• 00840194480116: VERTEGLIDE ROCKER
• 00840194480109: VERTEGLIDE REVERSE ACTION ROCKER
• 00840194480093: VERTEGLIDE 5.5MM CANNULATED TAP
• 00840194480086: VERTEGLIDE 4.5MM ROD BEND CHECKER
• 00840194480079: VERTEGLIDE 4.5MM CANNULATED TAP
• 00840194480062: VERTEGLIDE 4.0MM CANNULATED TAP
• 00840194480055: VERTEGLIDE 3.5MM TAP
• 00840194480048: 5.5 CLOSED VERTEGLIDE PEDICLE SCREW DRIVER
• 00840194480031: 5.5 OPEN VERTEGLIDE PEDICLE SCREW DRIVER
• 00840194480024: 4.5 CLOSED VERTEGLIDE PEDICLE SCREW DRIVER
• 00840194480017: 4.5 OPEN VERTEGLIDE PEDICLE SCREW DRIVER
• 00840194480000: NAVIGATED THORACIC LENKE PROBE
• 00840194479998: VERTEGLIDE FINAL TORQUE DRIVER
• 00840194479981: VERTEGLIDE 5.5mm MANUAL COUNTER TORQUE TUBE
• 00840194479974: VERTEGLIDE 4.5mm MANUAL COUNTER TORQUE TUBE
• 00840194479967: 5.5MM ROD CLAMP
• 00840194479950: 4.5MM ROD CLAMP
• 00840194479875: VERTEGLIDE 5.0MM CANNULATED TAP
• 00840194479868: 4.5MM PROVISIONAL ROD
• 00840194478632: VERTEGLIDE 5.5 ROD COCR, 500MM, 150MM FUSION
• 00840194478625: VERTEGLIDE 5.5 ROD COCR, 500MM, 90MM FUSION
• 00840194478618: VERTEGLIDE 4.5 ROD COCR, 500MM, 150MM FUSION
• 00840194478601: VERTEGLIDE 4.5 ROD COCR, 500MM, 90MM FUSION
• 00840194478595: VERTEGLIDE 5.5 ROD COCR, 500MM, 150MM FUSION, OFFSET
• 00840194478588: VERTEGLIDE 5.5 ROD COCR, 500MM, 90MM FUSION, OFFSET
• 00840194478571: VERTEGLIDE 4.5 ROD COCR, 500MM, 150MM FUSION, OFFSET
• 00840194478564: VERTEGLIDE 4.5 ROD COCR, 500MM, 90MM FUSION, OFFSET
• 00840194471947: CANNULATED LENKE PROBE BALL HANDLE
• 00840194471770: VERTEGLIDE 4.0MM SOLID TAP
• 00840194464994: VERTEGLIDE 5.5 ROD COCR, 500MM, 120MM FUSION