| Primary Device ID | 05056619801533 |
| NIH Device Record Key | 277ccfa7-11af-429d-bb15-8c5129e7c7b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axis Spine Technologies ALIF System Instrument |
| Version Model Number | AI-4810 |
| Catalog Number | AI-4810 |
| Company DUNS | 221947288 |
| Company Name | AXIS SPINE TECHNOLOGIES LTD |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05056619801533 [Primary] |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
[05056619801533]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-21 |
| Device Publish Date | 2024-06-13 |
| 05060771809900 | ALIF Endplate Alignment Tool |
| 05060771809894 | Disc Spreader Tip (Medium Straight) |
| 05060771809887 | Disc Spreader Tip (Small Straight) |
| 05060771809870 | ALIF Slim Tamp |
| 05060771809863 | Disc Spreader |
| 05060771809672 | Disc Spreader Tip (Medium Angled Right) |
| 05060771809665 | Disc Spreader Tip (Medium Angled Left) |
| 05060771809658 | Disc Spreader Tip (Small Angled Right) |
| 05060771809641 | Disc Spreader Tip (Small Angled Left) |
| 05060771809597 | ALIF Graft Tamp |
| 05060771809580 | ALIF Loading Block |
| 05060771809207 | T Handle (Sq) |
| 05060771808712 | ALIF Endplate Sizer Large Slim |
| 05060771808705 | ALIF Endplate Sizer Small Slim |
| 05060771808699 | ALIF Endplate Sizer Medium Slim |
| 05060771807760 | ALIF Tamp |
| 05060771806534 | ALIF Blocker Plate Remover |
| 05060771806510 | ALIF Inserter (Superior) |
| 05060771806473 | ALIF Core Trial - 8x30 |
| 05060771806459 | ALIF Core Trial - 6x30 |
| 05060771806350 | ALIF Core Trial - 8x25 |
| 05060771806336 | ALIF Core Trial - 6x25 |
| 05060771806251 | ALIF Core Trial - 10x20 |
| 05060771806237 | ALIF Core Trial - 8x20 |
| 05060771806213 | ALIF Core Trial - 6x20 |
| 05060771806138 | ALIF Core Trial - 10x15 |
| 05060771806114 | ALIF Core Trial - 8x15 |
| 05060771806091 | ALIF Core Trial - 6x15 |
| 05060771806015 | ALIF Core Trial - 10x10 |
| 05060771805995 | ALIF Core Trial - 8x10 |
| 05060771805971 | ALIF Core Trial - 6x10 |
| 05060771804608 | ALIF Endplate Sizer Large |
| 05060771804592 | ALIF Endplate Sizer Small |
| 05060771804585 | ALIF Endplate Sizer Medium |
| 05060771804110 | Straight Handle (Small AO) |
| 05060771804103 | ALIF Angled Screw Inserter Anti-Torque |
| 05060771804042 | ALIF Angled Screw Inserter |
| 05060771804028 | ALIF Screwdriver |
| 05060771804011 | T-Handle Small AO |
| 05060771803748 | ALIF Graft Syringe Medium |
| 05060771803588 | ALIF Slap Hammer |
| 05060771803502 | ALIF Graft Syringe Small |
| 05056619801052 | ALIF Core Loader |
| 05056619801045 | Paddle Distractor 12mm |
| 05056619801038 | Slotted Mallet |
| 05056619801007 | ALIF Curved Awl Long |
| 05056619800994 | ALIF Core Trial Inserter |
| 05056619800826 | ALIF Inserter Inferior |
| 05056619800819 | ALIF Inserter Superior |
| 05056619800802 | Disc Spreader Tip (Laminar Angled Right) |