| Primary Device ID | 00840311221455 |
| NIH Device Record Key | a5efd4c5-f979-4cde-a19d-f3ec1b4956e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cortera Spinal Fixation System |
| Version Model Number | 150101-90040 |
| Company DUNS | 081224143 |
| Company Name | Xtant Medical Holdings, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com | |
| Phone | +1(888)886-9354 |
| cs@xtantmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840311221455 [Primary] |
| NKB | Thoracolumbosacral pedicle screw system |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
[00840311221455]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-14 |
| Device Publish Date | 2024-10-04 |
| 00840311247929 | CORTERA, 30° ANGLED DEROTATOR |
| 00840311247967 | ROD INSERTER, MIS, 90DEG, SUB, BODY, MT, SLIM |
| 00840311254453 | Screw, Poly, Solid, 10.0x20 |
| 00840311254446 | Screw, Poly, Solid, 9.5x20 |
| 00840311254439 | Screw, Poly, Solid, 9.0x20 |
| 00840311254422 | Screw, Poly, Solid, 8.5x20 |
| 00840311254415 | Screw, Poly, Solid, 8.0x20 |
| 00840311254408 | Screw, Poly, Solid, 7.5x20 |
| 00840311254392 | Screw, Poly, Solid, 7.0x20 |
| 00840311254385 | Screw, Poly, Solid, 6.5x20 |
| 00840311254378 | Screw, Poly, Solid, 6.0x20 |
| 00840311254361 | Screw, Poly, Solid, 5.5x20 |
| 00840311254354 | Screw, Poly, Solid, 5.0x20 |
| 00840311254347 | Screw, Poly, Solid, 4.5x20 |
| 00840311254330 | Screw, Poly, Solid, 4.0x20 |
| 00840311253685 | Connector, Lateral Offset, Closed, 90mm |
| 00840311253678 | Connector, Lateral Offset, Closed, 70mm |
| 00840311253661 | Connector, Lateral Offset, Closed, 50mm |
| 00840311253654 | Connector, Lateral Offset, Closed, 30mm |
| 00840311253647 | Connector, Lateral Offset, Open, 90mm |
| 00840311253630 | Connector, Lateral Offset, Open, 70mm |
| 00840311253623 | Connector, Lateral Offset, Open, 30mm |
| 00840311253616 | Connector, Lateral Offset, Open, 50mm |
| 00840311253487 | Screw, Poly, MIS, Cann, 12.5x20 |
| 00840311253470 | Screw, Poly, MIS, Cann, 12.0x20 |
| 00840311253463 | Screw, Poly, MIS, Cann, 11.5x20 |
| 00840311253456 | Screw, Poly, MIS, Cann, 10.5x20 |
| 00840311253449 | SCREW, POLY, CANN, 12.5 x 60 |
| 00840311253432 | SCREW, POLY, CANN, 12.5 x 55 |
| 00840311253425 | SCREW, POLY, CANN, 12.5 x 50 |
| 00840311253418 | SCREW, POLY, CANN, 12.5 x 45 |
| 00840311253401 | SCREW, POLY, CANN, 12.5 x 40 |
| 00840311253395 | SCREW, POLY, CANN, 12.5 x 35 |
| 00840311253388 | SCREW, POLY, CANN, 12.5 x 30 |
| 00840311253371 | SCREW, POLY, CANN, 12.5 x 25 |
| 00840311253364 | SCREW, POLY, CANN, 12.5 x 20 |
| 00840311253357 | Screw, Poly, Cann, 12.0x60 |
| 00840311253340 | Screw, Poly, Cann, 12.0x55 |
| 00840311253333 | Screw, Poly, Cann, 12.0x50 |
| 00840311253326 | Screw, Poly, Cann, 12.0x45 |
| 00840311253319 | Screw, Poly, Cann, 12.0x40 |
| 00840311253302 | Screw, Poly, Cann, 12.0x35 |
| 00840311253296 | Screw, Poly, Cann, 12.0x30 |
| 00840311253289 | Screw, Poly, Cann, 12.0x25 |
| 00840311253272 | Screw, Poly, Cann, 12.0x20 |
| 00840311253265 | Screw, Poly, Cann, 11.5x60 |
| 00840311253258 | Screw, Poly, Cann, 11.5x55 |
| 00840311253241 | Screw, Poly, Cann, 11.5x50 |
| 00840311253234 | Screw, Poly, Cann, 11.5x45 |
| 00840311253227 | Screw, Poly, Cann, 11.5x40 |