| Primary Device ID | 00840200408585 |
| NIH Device Record Key | dff038b0-b501-476c-bfc1-c19280fe1bb7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Toro-L |
| Version Model Number | TL10-V12450 |
| Catalog Number | TL10-V12450 |
| Company DUNS | 080300717 |
| Company Name | INTEGRITY IMPLANTS 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840200408585 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
[00840200408585]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-07 |
| Device Publish Date | 2021-12-30 |
| 00840200408608 | V1 Toro-L 10° 14mm-24mm x 60mm |
| 00840200408592 | V1 Toro-L 10° 14mm-24mm x 55mm |
| 00840200408585 | V1 Toro-L 10° 14mm-24mm x 50mm |
| 00810004729650 | Secondary Retention Rod |
| 00810004729643 | Actuator Driver |
| 00810004729636 | Inserter Cap |
| 00810004729629 | Primary Retention Rod |
| 00810004729612 | Assembly, Lateral Inserter |
| 00084020040857 | V1 Toro-L 10° 14mm-24mm x 45mm |
| 00840200408578 | V1 Toro-L 10° 14mm-24mm x 45mm |
| 00840200409162 | 60mm Locking Rod |
| 00840200409155 | 55mm Locking Rod |
| 00840200409148 | 50mm Locking Rod |
| 00840200409131 | 45mm Locking Rod |
| 00840200408684 | Toro-L Inserter |
| 00840200404648 | Expansion Driver |
| 00840200404631 | Attachment Rod |
| 00840200404624 | 60mm Expansion Rod |
| 00840200404617 | 55mm Expansion Rod |
| 00840200404600 | 50mm Expansion Rod |
| 00840200404594 | 45mm Expansion Rod |
| 00840200404037 | Toro- L Graft Tube |
| 00810045539003 | 60mm Expandable Height Trial |
| 00810004729605 | 60mm Expandable Width Trial |
| 00810004729599 | 55mm Expandable Width Trial |
| 00810004729582 | 50mm Expandable Width Trial |
| 00810004729575 | 45mm Expandable Width Trial |
| 00840200403016 | Toro-L 10° x 14mm-24mm x 60mm |
| 00840200403009 | Toro-L 10° x 14mm-24mm x 55mm |
| 00840200402996 | Toro-L 10° x 14mm-24mm x 50mm |
| 00840200402989 | Toro-L 10° x 14mm-24mm x 45mm |