| Primary Device ID | 03662663146159 |
| NIH Device Record Key | 17739af1-3409-46ac-9318-ee55a47ba8e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gallery Laminoplasty Fixation System |
| Version Model Number | 14-523026 |
| Catalog Number | 14-523026 |
| Company DUNS | 119260394 |
| Company Name | Highridge Medical, LLC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663146159 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663146159]
Moist Heat or Steam Sterilization
[03662663146159]
Moist Heat or Steam Sterilization
[03662663146159]
Moist Heat or Steam Sterilization
[03662663146159]
Moist Heat or Steam Sterilization
[03662663146159]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-24 |
| Device Publish Date | 2025-11-15 |
| 03662663146517 | GALLERY 2.8X11MM S-D SCREW |
| 03662663146500 | GALLERY 2.8X9MM S-D SCREW |
| 03662663146494 | GALLERY 2.8X7MM S-D SCREW |
| 03662663146487 | GALLERY 2.8X5MM S-D SCREW |
| 03662663146470 | GALLERY 2.4X13MM S-D SCREW |
| 03662663146463 | GALLERY 2.4X11MM S-D SCREW |
| 03662663146456 | GALLERY 2.4X9MM S-D SCREW |
| 03662663146449 | GALLERY 2.4X7MM S-D SCREW |
| 03662663146432 | GALLERY 2.4X5MM S-D SCREW |
| 03662663146425 | GALLERY 2.0X13MM S-D SCREW |
| 03662663146418 | GALLERY 2.0X11MM S-D SCREW |
| 03662663146401 | GALLERY 2.0X9MM S-D SCREW |
| 03662663146395 | GALLERY 2.0X7MM S-D SCREW |
| 03662663146388 | GALLERY 2.0X5MM S-D SCREW |
| 03662663146371 | GALLERY 2.8X13MM S-T SCREW |
| 03662663146364 | GALLERY 2.8X11MM S-T SCREW |
| 03662663146357 | GALLERY 2.8X9MM S-T SCREW |
| 03662663146340 | GALLERY 2.8X7MM S-T SCREW |
| 03662663146333 | GALLERY 2.8X5MM S-T SCREW |
| 03662663146326 | GALLERY 2.4X13MM S-T SCREW |
| 03662663146319 | GALLERY 2.4X11MM S-T SCREW |
| 03662663146302 | GALLERY 2.4X9MM S-T SCREW |
| 03662663146296 | GALLERY 2.4X7MM S-T SCREW |
| 03662663146289 | GALLERY 2.4X5MM S-T SCREW |
| 03662663146272 | GALLERY 2.0X13MM S-T SCREW |
| 03662663146265 | GALLERY 2.0X11MM S-T SCREW |
| 03662663146258 | GALLERY 2.0X9MM S-T SCREW |
| 03662663146241 | GALLERY 2.0X7MM S-T SCREW |
| 03662663146234 | GALLERY 2.0X5MM S-T SCREW |
| 03662663146227 | GALLERY PLATE BENDER |
| 03662663146210 | GALLERY SCREW DRIVER |
| 03662663146203 | GALLERY STANDARD AWL 2.0MM DIA |
| 03662663146197 | 2.4MM X 11MM GALLERY DRILL |
| 03662663146180 | 2.4MM X 9MM GALLERY DRILL |
| 03662663146173 | 2.4MM X 7MM GALLERY DRILL |
| 03662663146166 | 2.4MM X 5MM GALLERY DRILL |
| 03662663146159 | GALLERY 60 DEGREE PLATE HOLDER |
| 03662663146142 | GALLERY 25 DEGREE PLATE HOLDER |
| 03662663146135 | GALLERY QUICK CONNECT HANDLE |
| 03662663146128 | 14MM GALLERY TRIAL |
| 03662663146111 | GALLERY 12MM TRIAL |
| 03662663146104 | GALLERY 10MM TRIAL |
| 03662663146098 | GALLERY 8MM TRIAL |
| 03662663146081 | SURGICAL TRAY, GALLERY |
| 03662663146623 | GALLERY 16MM PLATE WITH HOOK |
| 03662663146616 | GALLERY 14MM PLATE WITH HOOK |
| 03662663146609 | GALLERY 12MM PLATE WITH HOOK |
| 03662663146593 | GALLERY 10MM PLATE WITH HOOK |
| 03662663146586 | GALLERY 8MM PLATE WITH HOOK |
| 03662663146579 | GALLERY 16MM STANDARD PLATE |