| Primary Device ID | 00840194493819 |
| NIH Device Record Key | 41ef37c3-a462-493d-8f18-da690fb65cc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VerteGlide Spinal Growth Guidance System |
| Version Model Number | 03-1721-4502 |
| Catalog Number | 03-1721-4502 |
| Company DUNS | 796416191 |
| Company Name | ORTHOPEDIATRICS CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com | |
| Phone | +1(574)268-6379 |
| xxx@xxx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840194493819 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
[00840194493819]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-18 |
| Device Publish Date | 2025-07-10 |
| 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 |