| Primary Device ID | 18257200118168 |
| NIH Device Record Key | 750e17d9-322c-491d-9e66-cb8ee5785d47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PILLAR SA |
| Version Model Number | 450295-0002 |
| Catalog Number | 49-0021 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com | |
| Phone | +1(800)527-0404 |
| customerservice@orthofix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200118168 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
[18257200118168]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2019-03-19 |
| 18257200118168 | PILLAR SA INST (49-0021) |
| 18257200081943 | CADDY, 43W X 32D X 12DEG (49-4422) |
| 18257200081936 | CADDY, 43W X 28D X 12DEG (49-4412) |
| 18257200081929 | CADDY, 43W X 32D X 7DEG (49-4317) |
| 18257200081912 | CADDY, 43W X 28D X 7DEG (49-4307) |
| 18257200081851 | CADDY, 40W X 32D X 12DEG (49-4132) |
| 18257200081844 | CADDY, 40W X 32D X 7DEG (49-4017) |
| 18257200081837 | CADDY, 37W X 32D X 12DEG (49-3722) |
| 18257200081820 | CADDY, 37W X 32D X 7DEG (49-3717) |
| 18257200081813 | CADDY, 33W X 32D X 12DEG (49-3332) |
| 18257200081806 | CADDY, 33W X 32D X 7DEG (49-3317) |
| 18257200081790 | CADDY, 40W X 28D X 12DEG (49-4122) |
| 18257200081783 | CADDY, 40W X 28D X 7DEG (49-4007) |
| 18257200081776 | CADDY, 37W X 28D X 12DEG (49-3712) |
| 18257200081769 | CADDY, 37W X 28D X 7DEG (49-3707) |
| 18257200081752 | CADDY, 33W X 28D X 12DEG (49-3322) |
| 18257200081745 | CADDY, 33W X 28D X 7DEG (49-3307) |
| 18257200081738 | PILLAR SA IMPLANTS AND TRIALS (49-0011) |
| 18257200045143 | PILLAR SA TRIAL 33X32X20, 12DEG LORDOTIC |
| 18257200045136 | PILLAR SA TRIAL 33X32X18, 12DEG LORDOTIC |
| 18257200045129 | PILLAR SA TRIAL 33X32X16, 12DEG LORDOTIC |
| 18257200045112 | PILLAR SA TRIAL 33X32X14, 12DEG LORDOTIC |
| 18257200045105 | PILLAR SA TRIAL 33X32X12.5, 12DEG LORDOTIC |
| 18257200045099 | PILLAR SA TRIAL 33X32X20, 7DEG LORDOTIC |
| 18257200045082 | PILLAR SA TRIAL 33X32X18, 7DEG LORDOTIC |
| 18257200045075 | PILLAR SA TRIAL 33X32X16, 7DEG LORDOTIC |
| 18257200045068 | PILLAR SA TRIAL 33X32X14, 7DEG LORDOTIC |
| 18257200045051 | PILLAR SA TRIAL 33X32X12.5, 7DEG LORDOTIC |
| 18257200045044 | PILLAR SA TRIAL 33X28X20, 12DEG LORDOTIC |
| 18257200045037 | PILLAR SA TRIAL 33X28X18, 12DEG LORDOTIC |
| 18257200045020 | PILLAR SA TRIAL 33X28X16, 12DEG LORDOTIC |
| 18257200045013 | PILLAR SA TRIAL 33X28X14, 12DEG LORDOTIC |
| 18257200045006 | PILLAR SA TRIAL 33X28X12.5, 12DEG LORDOTIC |
| 18257200044993 | PILLAR SA TRIAL 33X28X20, 7DEG LORDOTIC |
| 18257200044986 | PILLAR SA TRIAL 33X28X18, 7DEG LORDOTIC |
| 18257200044979 | PILLAR SA TRIAL 33X28X16, 7DEG LORDOTIC |
| 18257200044962 | PILLAR SA TRIAL 33X28X14, 7DEG LORDOTIC |
| 18257200044955 | PILLAR SA TRIAL 33X28X12.5, 7DEG LORDOTIC |
| 18257200044948 | PILLAR SA TRIAL 43X32X20, 12DEG LORDOTIC |
| 18257200044931 | PILLAR SA TRIAL 43X32X18, 12DEG LORDOTIC |
| 18257200044924 | PILLAR SA TRIAL 43X32X16, 12DEG LORDOTIC |
| 18257200044917 | PILLAR SA TRIAL 43X32X14, 12DEG LORDOTIC |
| 18257200044900 | PILLAR SA TRIAL 43X32X12.5, 12DEG LORDOTIC |
| 18257200044894 | PILLAR SA TRIAL 43X32X20, 7DEG LORDOTIC |
| 18257200044887 | PILLAR SA TRIAL 43X32X18, 7DEG LORDOTIC |
| 18257200044870 | PILLAR SA TRIAL 43X32X16, 7DEG LORDOTIC |
| 18257200044863 | PILLAR SA TRIAL 43X32X14, 7DEG LORDOTIC |
| 18257200044856 | PILLAR SA TRIAL 43X32X12.5, 7DEG LORDOTIC |
| 18257200044849 | PILLAR SA TRIAL 40X32X20, 12DEG LORDOTIC |
| 18257200044832 | PILLAR SA TRIAL 40X32X18, 12DEG LORDOTIC |