| Primary Device ID | 18257200037957 |
| NIH Device Record Key | 06fa4ed4-4fe4-48bc-aff0-8ad928be1976 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONSTRUX - PEEK VBR |
| Version Model Number | 45-2106 |
| 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 | 18257200037957 [Primary] |
| MQP | Spinal vertebral body replacement device |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
Moist Heat or Steam Sterilization
[18257200037957]
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 |
| 18257200081257 | CONSTRUX PEEK VBR SYSTEM, IMPLANT AND INSTRUMENT CASE (45-0011) |
| 18257200081240 | CONSTRUX PEEK VBR SYSTEM, INSTRUMENT CASE 2 (45-0020) |
| 18257200081233 | CONSTRUX PEEK VBR IMPLANT SYSTEM - CASE 1 (45-0010) |
| 18257200043071 | PILLAR AL TRIAL 34X28X24, 12DEG LORDOTIC |
| 18257200043064 | PILLAR AL TRIAL 34X28X22, 12DEG LORDOTIC |
| 18257200043057 | PILLAR AL TRIAL 34X28X20, 12DEG LORDOTIC |
| 18257200043040 | PILLAR AL TRIAL 34X28X18, 12DEG LORDOTIC |
| 18257200043033 | PILLAR AL TRIAL 34X28X16, 12DEG LORDOTIC |
| 18257200043026 | PILLAR AL TRIAL 34X28X14, 12DEG LORDOTIC |
| 18257200043019 | PILLAR AL TRIAL 34X28X12, 12DEG LORDOTIC |
| 18257200043002 | PILLAR AL 34MM X 28MM X 22MM TRIAL 7DEG LORDOTIC |
| 18257200042999 | PILLAR AL 34MM X 28MM X 20MM TRIAL 7DEG LORDOTIC |
| 18257200042982 | PILLAR AL 34MM X 28MM X 18MM TRIAL 7DEG LORDOTIC |
| 18257200042975 | PILLAR AL 34MM X 28MM X 16MM TRIAL 7DEG LORDOTIC |
| 18257200042968 | PILLAR AL 34MM X 28MM X 14MM TRIAL 7DEG LORDOTIC |
| 18257200042951 | PILLAR AL 34MM X 28MM X 12MM TRIAL 7DEG LORDOTIC |
| 18257200042944 | PILLAR AL 24MM X 28MM X 10MM TRIAL 7DEG LORDOTIC |
| 18257200042920 | PILLAR AL TRIAL 34X28X20 0DEG 30MM X 34MMX 20MM,0DEG LORDOTIC |
| 18257200042913 | PILLAR AL TRIAL 34X28X18 0DEG 30MM X 34MMX 18MM,0DEG LORDOTIC |
| 18257200042906 | PILLAR AL TRIAL 34X28X16 0DEG 30MM X 34MMX 16MM,0DEG LORDOTIC |
| 18257200042890 | PILLAR AL TRIAL 34X28X14 0DEG 30MM X 34MMX 14MM,0DEG LORDOTIC |
| 18257200042883 | PILLAR AL TRIAL 34X28X12 0DEG 30MM X 34MMX 12MM,0DEG LORDOTIC |
| 18257200042876 | PILLAR AL TRIAL 34X28X10 0DEG 30MM X 34MMX 10MM,0DEG LORDOTIC |
| 18257200042869 | PILLAR AL TRIAL 34X28X8 0DEG 30MM X 34MMX 8MM,0DEG LORDOTIC |
| 18257200042852 | PILLAR AL TRIAL 30X24X24, 12DEG LORDOTIC |
| 18257200042845 | PILLAR AL TRIAL 30X24X22, 12DEG LORDOTIC |
| 18257200042838 | PILLAR AL TRIAL 30X24X20, 12DEG LORDOTIC |
| 18257200042821 | PILLAR AL TRIAL 30X24X18, 12DEG LORDOTIC |
| 18257200042814 | PILLAR AL TRIAL 30X24X16, 12DEG LORDOTIC |
| 18257200042807 | PILLAR AL TRIAL 30X24X14, 12DEG LORDOTIC |
| 18257200042791 | PILLAR AL TRIAL 30X24X12, 12DEG LORDOTIC |
| 18257200042784 | PILLAR AL TRIAL 30X24X22, 7DEG LORDOTIC |
| 18257200042777 | PILLAR AL TRIAL 30X24X20, 7DEG LORDOTIC |
| 18257200042760 | PILLAR AL TRIAL 30X24X18, 7DEG LORDOTIC |
| 18257200042753 | PILLAR AL TRIAL 30X24X16, 7DEG LORDOTIC |
| 18257200042746 | PILLAR AL TRIAL 30X24X14, 7DEG LORDOTIC |
| 18257200042739 | PILLAR AL TRIAL 30X24X12, 7DEG LORDOTIC |
| 18257200042722 | PILLAR AL TRIAL 30X24X10, 7DEG LORDOTIC |
| 18257200042715 | PILLAR AL TRIAL 30X24X18 PARALLEL |
| 18257200042708 | PILLAR AL TRIAL 30X24X16 PARALLEL |
| 18257200042692 | PILLAR AL TRIAL 30X24X14 PARALLEL |
| 18257200042685 | PILLAR AL TRIAL 30X24X12 PARALLEL |
| 18257200042678 | PILLAR AL TRIAL 30X24X10 PARALLEL |
| 18257200042661 | PILLAR AL TRIAL 30X24X8 PARALLEL |
| 18257200042654 | PILLAR AL TRIAL 26X20X24 12DEG 26MM X 20MMX 24MM,12DEG LORDOTIC |
| 18257200042647 | PILLAR AL TRIAL 26X20X22 12DEG 26MM X 20MMX 22MM,12DEG LORDOTIC |
| 18257200042630 | PILLAR AL TRIAL 26X20X20 12DEG 26MM X 20MMX 20MM,12DEG LORDOTIC |
| 18257200042623 | PILLAR AL TRIAL 26X20X18 12DEG 26MM X 20MMX 18MM,12DEG LORDOTIC |
| 18257200042616 | PILLAR AL TRIAL 26X20X16 12DEG 26MM X 20MMX 16MM,12DEG LORDOTIC |
| 18257200042609 | PILLAR AL TRIAL 26X20X14 12DEG 26MM X 20MMX 14MM,12DEG LORDOTIC |