| Primary Device ID | 18257200041923 |
| NIH Device Record Key | e0c68678-53df-4a0d-956e-f1e59c319618 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONSTRUX - MINI PEEK VBR |
| Version Model Number | 47-3009 |
| 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 | 18257200041923 [Primary] |
| ODP | Intervertebral fusion device with bone graft, cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
Moist Heat or Steam Sterilization
[18257200041923]
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 |
| 18257200135813 | IMPLANT INSERTER ASSEMBLY |
| 18257200082957 | CONSTRUX MINI PEEK SPACER SYSTEM - INSTRUMENT KIT (47-0012) |
| 18257200081370 | CONSTRUX MINI, SPACER AND VBR SYSTEMS (47-0010) |
| 18257200042357 | CONSTRUX MINI 15MM W X 12MM D X 14MM H, PARALLEL |
| 18257200042340 | CONSTRUX MINI 14MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042333 | CONSTRUX MINI 15MM W X 12MM D X 13MM H, PARALLEL |
| 18257200042326 | CONSTRUX MINI 13MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042319 | CONSTRUX MINI 12MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042302 | CONSTRUX MINI 11MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042296 | CONSTRUX MINI 10MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042289 | CONSTRUX MINI 9MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042272 | CONSTRUX MINI 8MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042265 | CONSTRUX MINI 7MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042258 | CONSTRUX MINI 6MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042241 | CONSTRUX MINI 5MM H X 15MM W X 12MM L - PARALLEL |
| 18257200042234 | CONSTRUX MINI 15MM W X 12MM D X 14MM H, 5? LORDOTIC |
| 18257200042227 | CONSTRUX MINI 14MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042210 | CONSTRUX MINI 15MM W X 12MM D X 13MM H, 5? LORDOTIC |
| 18257200042203 | CONSTRUX MINI 13MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042197 | CONSTRUX MINI 12MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042180 | CONSTRUX MINI 11MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042173 | CONSTRUX MINI 10MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042166 | CONSTRUX MINI 9MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042159 | CONSTRUX MINI 8MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042142 | CONSTRUX MINI 7MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042135 | CONSTRUX MINI 6MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042128 | CONSTRUX MINI 5MM H X 15MM W X 12MM L - 5DEG LORDOTIC |
| 18257200042111 | CONSTRUX MINI 12MM W X 12MM D X 14MM H, PARALLEL |
| 18257200042104 | CONSTRUX MINI 14MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042098 | CONSTRUX MINI 12MM W X 12MM D X 13MM H, PARALLEL |
| 18257200042081 | CONSTRUX MINI 13MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042074 | CONSTRUX MINI 12MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042067 | CONSTRUX MINI 11MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042050 | CONSTRUX MINI 10MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042043 | CONSTRUX MINI 9MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042036 | CONSTRUX MINI 8MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042029 | CONSTRUX MINI 7MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042012 | CONSTRUX MINI 6MM H X 12MM W X 12MM L - PARALLEL |
| 18257200042005 | CONSTRUX MINI 5MM H X 12MM W X 12MM L - PARALLEL |
| 18257200041992 | CONSTRUX MINI 12MM W X 12MM D X 14MM H, 5? LORDOTIC |
| 18257200041985 | CONSTRUX MINI 14MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041978 | CONSTRUX MINI 12MM W X 12MM D X 13MM H, 5? LORDOTIC |
| 18257200041961 | CONSTRUX MINI 13MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041954 | CONSTRUX MINI 12MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041947 | CONSTRUX MINI 11MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041930 | CONSTRUX MINI 10MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041923 | CONSTRUX MINI 9MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041916 | CONSTRUX MINI 8MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041909 | CONSTRUX MINI 7MM H X 12MM W X 12MM L - 5DEG LORDOTIC |
| 18257200041893 | CONSTRUX MINI 6MM H X 12MM W X 12MM L - 5DEG LORDOTIC |