| Primary Device ID | 03662663155038 |
| NIH Device Record Key | c0df2192-39fa-46c0-9627-d9939581b002 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zyston Interbody Spacer System |
| Version Model Number | 14-533046 |
| Catalog Number | 14-533046 |
| 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 | 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 |
| 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 | 03662663155038 [Primary] |
| HXG | TAMP |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663155038]
Moist Heat or Steam Sterilization
[03662663155038]
Moist Heat or Steam Sterilization
[03662663155038]
Moist Heat or Steam Sterilization
[03662663155038]
Moist Heat or Steam Sterilization
[03662663155038]
Moist Heat or Steam Sterilization
[03662663155038]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-21 |
| Device Publish Date | 2025-11-13 |
| 03662663155069 | CURVE CARRYING CASE, PARALLEL |
| 03662663155052 | CURVE MIS TRIAL HOLDER SHAFT |
| 03662663155045 | CURVE MIS TRIAL HOLDER |
| 03662663155038 | CURVE STARTER TAMP |
| 03662663155014 | CURVE TRIAL HOLDER SHAFT |
| 03662663154994 | CURVE TRIAL 18HX32L 0 DEG |
| 03662663154987 | CURVE TRIAL 17HX32L 0 DEG |
| 03662663154970 | CURVE TRIAL 16HX32L 0 DEG |
| 03662663154963 | CURVE TRIAL 15HX32L 0 DEG |
| 03662663154956 | CURVE TRIAL 14HX32L 0 DEG |
| 03662663154949 | CURVE TRIAL 13HX32L 0 DEG |
| 03662663154932 | CURVE TRIAL 12HX32L 0 DEG |
| 03662663154925 | CURVE TRIAL 11HX32L 0 DEG |
| 03662663154918 | CURVE TRIAL 10HX32L 0 DEG |
| 03662663154901 | CURVE TRIAL 9HX32L 0 DEG |
| 03662663154895 | CURVE TRIAL 8HX32L 0 DEG |
| 03662663154888 | CURVE TRIAL 7HX32L 0 DEG |
| 03662663154871 | CURVE TRIAL 6HX32L 0 DEG |
| 03662663154864 | CURVE ANGLED TAMP |
| 03662663154857 | CURVE STRAIGHT TAMP |
| 03662663154840 | CURVE IMPLANT REMOVER |
| 03662663154833 | CURVE TRIAL 18HX27L 0 DEG |
| 03662663154826 | CURVE TRIAL 17HX27L 0 DEG |
| 03662663154819 | CURVE TRIAL 16HX27L 0 DEG |
| 03662663154802 | CURVE TRIAL 15HX27L 0 DEG |
| 03662663154796 | CURVE TRIAL 14HX27L 0 DEG |
| 03662663154789 | CURVE TRIAL 13HX27L 0 DEG |
| 03662663154772 | CURVE TRIAL 12HX27L 0 DEG |
| 03662663154765 | CURVE TRIAL 11HX27L 0 DEG |
| 03662663154758 | CURVE TRIAL 10HX27L 0 DEG |
| 03662663154741 | CURVE TRIAL 9HX27L 0 DEG |
| 03662663154734 | CURVE TRIAL 8HX27L 0 DEG |
| 03662663154727 | CURVE TRIAL 7HX27L 0 DEG |
| 03662663154710 | CURVE TRIAL 6HX27L 0 DEG |
| 03662663130967 | Curved Trial 33L x 10H x 10W mm |
| 03662663130950 | Curved Trial 33L x 09H x 10W mm |
| 03662663130943 | Curved Trial 33L x 08H x 10W mm |
| 03662663130912 | Curved Trial 28L x 16H x 11W mm |
| 03662663130905 | Curved Trial 28L x 15H x 11W mm |
| 03662663130899 | Curved Trial 28L x 14H x 11W mm |
| 03662663130882 | Curved Trial 28L x 13H x 11W mm |
| 03662663130875 | Curved Trial 28L x 12H x 10W mm |
| 03662663130868 | Curved Trial 28L x 11H x 10W mm |
| 03662663130851 | Curved Trial 28L x 10H x 10W mm |
| 03662663130844 | Curved Trial 28L x 09H x 10W mm |
| 03662663130837 | Curved Trial 28L x 08H x 10W mm |
| 03662663130820 | Curved Trial 28L x 07H x 10W mm |
| 03662663192941 | FORCEPS BIPOLAR DIA1.0MM ANGLED TIPS |
| 03662663192934 | FORCEPS BIPOLAR DIA1.5MM STRAIGHT TIPS |
| 03662663131216 | Straight Trial 26L x 16H x 11W mm |