| Primary Device ID | 18257200122745 |
| NIH Device Record Key | 6021af4f-4f49-460c-a83f-704ced4b7b06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FORZA XP |
| Version Model Number | 28-3140 |
| 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 | 18257200122745 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
Moist Heat or Steam Sterilization
[18257200122745]
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 |
| 18257200142613 | FORZA XP - IMPLANT/INSTRUMENT TRAY KIT (28-9092) |
| 18257200142163 | FUNNEL PLUNGER |
| 18257200140930 | FORZA XP - IMPLANT/INSTRUMENT TRAY KIT (28-9091) |
| 18257200135479 | IMPLANT INSERTER ASSEMBLY |
| 18257200131433 | IMPLANT REMOVER DRIVER |
| 18257200131402 | IMPLANT REMOVER |
| 18257200130672 | FORZA XP - IMPLANT/INSTRUMENT TRAY KIT (28-9091) |
| 18257200130665 | FORZA XP - IMPLANT CADDY, IMPLANT/INSTRUMENT CASE |
| 18257200130658 | FORZA XP - BOTTOM TRAY-LEVEL, IMPLANT/INSTRUMENT CASE |
| 18257200130641 | FORZA XP - TOP TRAY-LEVEL, IMPLANT/INSTRUMENT CASE |
| 18257200130634 | FORZA XP - BASE, IMPLANT/INSTRUMENT CASE |
| 18257200130627 | FORZA XP - IMPLANT/INSTRUMENT CASE |
| 18257200130573 | TORQUE LIMITING HANDLE |
| 18257200130566 | AXIAL TORQUE LIMITING HANDLE |
| 18257200126323 | IMPLANT DRIVER |
| 18257200126316 | SLAP HAMMER ASSEMBLY |
| 18257200126309 | FUNNEL |
| 18257200126293 | FUNNEL PLUNGER |
| 18257200126286 | 12.5 H x 10 W TRIAL |
| 18257200126279 | 10.5 H x 10 W TRIAL |
| 18257200126262 | 8.5 H x 10 W TRIAL |
| 18257200126255 | 6.5 H x 10 W TRIAL |
| 18257200126248 | IMPLANT STABILIZER ASSEMBLY |
| 18257200126231 | IMPLANT INSERTER ASSEMBLY |
| 18257200123131 | 12.5MM X 12MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY |
| 18257200123124 | 10.5MM X 12MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY |
| 18257200123117 | 8.5MM X 12MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY |
| 18257200123100 | 12.5MM X 12MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY |
| 18257200123094 | 10.5MM X 12MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY |
| 18257200123087 | 8.5MM X 12MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY |
| 18257200123070 | 12.5MM X 10MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY |
| 18257200123063 | 10.5MM X 10MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY |
| 18257200123056 | 8.5MM X 10MM WIDE X 28MM HYPERLORDOTIC ASSEMBLY |
| 18257200123049 | 12.5MM X 10MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY |
| 18257200123032 | 10.5MM X 10MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY |
| 18257200123025 | 8.5MM X 10MM WIDE X 24MM HYPERLORDOTIC ASSEMBLY |
| 18257200123001 | 12.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY |
| 18257200122981 | 10.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY |
| 18257200122967 | 8.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY |
| 18257200122943 | 12.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY |
| 18257200122929 | 10.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY |
| 18257200122905 | 8.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY |
| 18257200122882 | 12.5MM X 10MM WIDE X 28MM LORDOTIC ASSEMBLY |
| 18257200122868 | 10.5MM X 10MM WIDE X 28MM LORDOTIC ASSEMBLY |
| 18257200122844 | 8.5MM X 10MM WIDE X 28MM LORDOTIC ASSEMBLY |
| 18257200122820 | 12.5MM X 10MM WIDE X 24MM LORDOTIC ASSEMBLY |
| 18257200122806 | 10.5MM X 10MM WIDE X 24MM LORDOTIC ASSEMBLY |
| 18257200122783 | 8.5MM X 10MM WIDE X 24MM LORDOTIC ASSEMBLY |
| 18257200122776 | 6.5MM X 12MM WIDE X 28MM LORDOTIC ASSEMBLY |
| 18257200122769 | 6.5MM X 12MM WIDE X 24MM LORDOTIC ASSEMBLY |