| Primary Device ID | 18257200031115 |
| NIH Device Record Key | 23a054a0-9362-46d4-b00f-c6cacc7ce3c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONSTRUX - MINI PTC |
| Version Model Number | 37-4114SP |
| 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 | 18257200031115 [Primary] |
| ODP | Intervertebral fusion device with bone graft, cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
Moist Heat or Steam Sterilization
[18257200031115]
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 |
| 18257200132690 | DOUBLE ENDED TRIAL - 15MM W X 15MM D X 12MM/13MM H, 5DEG LORDOTIC |
| 18257200132676 | DOUBLE ENDED TRIAL - 15MM W X 15MM D X 10MM/11MM H, 5DEG LORDOTIC |
| 18257200132652 | DOUBLE ENDED TRIAL - 15MM W X 15MM D X 8MM/9MM H, 5DEG LORDOTIC |
| 18257200132638 | DOUBLE ENDED TRIAL - 15MM W X 15MM D X 6MM/7MM H, 5DEG LORDOTIC |
| 18257200132591 | DOUBLE ENDED TRIAL -15MM W X 12MM D X 12MM/13MM H, 5DEG LORDOTIC |
| 18257200132577 | DOUBLE ENDED TRIAL -15MM W X 12MM D X 10MM/11MM H, 5DEG LORDOTIC |
| 18257200132553 | DOUBLE ENDED TRIAL -15MM W X 12MM D X 8MM/9MM H, 5DEG LORDOTIC |
| 18257200132539 | DOUBLE ENDED TRIAL -15MM W X 12MM D X 6MM/7MM H, 5DEG LORDOTIC |
| 18257200132492 | DOUBLE ENDED TRIAL -12MM W X 12MM D X 12MM/13MM H, 5DEG LORDOTIC |
| 18257200132478 | DOUBLE ENDED TRIAL -12MM W X 12MM D X 10MM/11MM H, 5DEG LORDOTIC |
| 18257200132454 | DOUBLE ENDED TRIAL -12MM W X 12MM D X 8MM/9MM H, 5DEG LORDOTIC |
| 18257200132430 | DOUBLE ENDED TRIAL -12MM W X 12MM D X 6MM/7MM H, 5DEG LORDOTIC |
| 18257200132416 | RASP - 15MM W X 12MM D X 14MM H, 5DEG LORDOTIC |
| 18257200132409 | RASP - 15MM W X 12MM D X 13MM H, 5DEG LORDOTIC |
| 18257200132393 | RASP - 15MM W X 12MM D X 12MM H, 5DEG LORDOTIC |
| 18257200132386 | RASP - 15MM W X 12MM D X 11MM H, 5DEG LORDOTIC |
| 18257200132379 | RASP - 15MM W X 12MM D X 10MM H, 5DEG LORDOTIC |
| 18257200132362 | RASP - 15MM W X 12MM D X 9MM H, 5DEG LORDOTIC |
| 18257200132355 | RASP - 15MM W X 12MM D X 8MM H, 5DEG LORDOTIC |
| 18257200132348 | RASP - 15MM W X 12MM D X 7MM H, 5DEG LORDOTIC |
| 18257200132331 | RASP - 15MM W X 12MM D X 6MM H, 5DEG LORDOTIC |
| 18257200132317 | RASP - 12MM W X 12MM D X 14MM H, 5DEG LORDOTIC |
| 18257200132300 | RASP - 12MM W X 12MM D X 13MM H, 5DEG LORDOTIC |
| 18257200132294 | RASP - 12MM W X 12MM D X 12MM H, 5DEG LORDOTIC |
| 18257200132287 | RASP - 12MM W X 12MM D X 11MM H, 5DEG LORDOTIC |
| 18257200132270 | RASP - 12MM W X 12MM D X 10MM H, 5DEG LORDOTIC |
| 18257200132263 | RASP - 12MM W X 12MM D X 9MM H, 5DEG LORDOTIC |
| 18257200132256 | RASP - 12MM W X 12MM D X 8MM H, 5DEG LORDOTIC |
| 18257200132249 | RASP - 12MM W X 12MM D X 7MM H, 5DEG LORDOTIC |
| 18257200132232 | RASP - 12MM W X 12MM D X 6MM H, 5DEG LORDOTIC |
| 18257200093816 | COMPLETE IMPLANT SET - CONSTRUX MINI PTC SPACER SYSTEM |
| 18257200082452 | 15MM X 15MM - TRIAL SIZERS WITH CADDY - COMPLETE ASSEMBLY, CONSTRUX MINI PEEK SPACER SYSTEM (37- |
| 18257200031672 | CADDY ASSEMBLY, 15MM X 15MM - TRIAL SIZERS - CONSTRUX MINI PEEK SPACER SYSTEM |
| 18257200031658 | 15MM L X 15MM W, 14 MM H, PARALLEL TRIAL |
| 18257200031641 | 15MM L X 15MM W, 13 MM H, PARALLEL TRIAL |
| 18257200031634 | 15MM L X 15MM W, 12 MM H, PARALLEL TRIAL |
| 18257200031627 | 15MM L X 15MM W, 11 MM H, PARALLEL TRIAL |
| 18257200031610 | 15MM L X 15MM W, 10 MM H, PARALLEL TRIAL |
| 18257200031603 | 15MM L X 15MM W, 9 MM H, PARALLEL TRIAL |
| 18257200031597 | 15MM L X 15MM W, 8 MM H, PARALLEL TRIAL |
| 18257200031580 | 15MM L X 15MM W, 7 MM H, PARALLEL TRIAL |
| 18257200031573 | 15MM L X 15MM W, 6 MM H, PARALLEL TRIAL |
| 18257200031566 | 15MM L X 15MM W, 14 MM H, LORDOTIC TRIAL |
| 18257200031559 | 15MM L X 15MM W, 13 MM H, LORDOTIC TRIAL |
| 18257200031542 | 15MM L X 15MM W, 12 MM H, LORDOTIC TRIAL |
| 18257200031535 | 15MM L X 15MM W, 11 MM H, LORDOTIC TRIAL |
| 18257200031528 | 15MM L X 15MM W, 10 MM H, LORDOTIC TRIAL |
| 18257200031511 | 15MM L X 15MM W, 9 MM H, LORDOTIC TRIAL |
| 18257200031504 | 15MM L X 15MM W, 8 MM H, LORDOTIC TRIAL |
| 18257200031498 | 15MM L X 15MM W, 7 MM H, LORDOTIC TRIAL |