| Primary Device ID | 00190837101657 |
| NIH Device Record Key | de363ef3-2c5b-498c-ad9c-17bfb84c9c09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aileron |
| Version Model Number | 132-3-006 |
| Catalog Number | 132-3-006 |
| Company DUNS | 183641617 |
| Company Name | Life Spine, 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 | 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 | 00190837101657 [Primary] |
| PEK | Spinous process plate |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837101657]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2019-11-19 |
| 00190837091507 | HEX DRIVER AILERON |
| 00190837091491 | PUNCH, AILERON, LARGE |
| 00190837091484 | PUNCH, AILERON, MEDIUM |
| 00190837091477 | PUNCH, AILERON, SMALL |
| 00190837091460 | SLEEVE, 18MM |
| 00190837091453 | SLEEVE, 16MM |
| 00190837091439 | SLEEVE, 12MM |
| 00190837091422 | SLEEVE, 10MM |
| 00190837091415 | SLEEVE, 7MM |
| 00190837091408 | SLEEVE, 5MM |
| 00190837091385 | Static Aileron Implant Caddy - Small |
| 00190837091347 | All-In-One Inserter, Aileron TRX |
| 00190837091293 | VICE GRIPS |
| 00190837043667 | Punch, Aileron, Medium |
| 00190837043513 | Static Aileron Implant Caddy - Small |
| 00190837101732 | Interspinous Punch 6mm |
| 00190837101725 | Interspinous Punch 4mm |
| 00190837101718 | Interspinous Rasp, 18mm |
| 00190837101701 | Interspinous Rasp, 16mm |
| 00190837101695 | Interspinous Rasp, 14mm |
| 00190837101688 | Interspinous Rasp, 12mm |
| 00190837101671 | Interspinous Rasp, 10mm |
| 00190837101664 | Interspinous Rasp, 8mm |
| 00190837101657 | Interspinous Rasp, 6mm |
| 00190837101640 | Interspinous Rasp, 4mm |
| 00190837091446 | SLEEVE, 14MM |