| Primary Device ID | 18257200092321 |
| NIH Device Record Key | b4636896-5bed-40f0-8f00-8c94ca2f6700 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FORZA PTC |
| Version Model Number | 38-4514SP |
| 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 | 18257200092321 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
Moist Heat or Steam Sterilization
[18257200092321]
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 | 2019-03-12 |
| 18257200111411 | 11W X 27L X 11H, 0DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200111404 | 9W X 23L X 10H, 0DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200111305 | 11W X 27L X 13H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092321 | 9W X 27L X 14H, 8DEG CURVED PTC IMPLANT, STERILE |
| 18257200092314 | 9W X 27L X 13H, 8DEG CURVED PTC IMPLANT, STERILE |
| 18257200092307 | 9W X 27L X 12H, 8DEG CURVED PTC IMPLANT, STERILE |
| 18257200092291 | 9W X 27L X 11H, 8DEG CURVED PTC IMPLANT, STERILE |
| 18257200092284 | 9W X 27L X 10H, 8DEG CURVED PTC IMPLANT, STERILE |
| 18257200092277 | 9W X 27L X 9H, 8DEG CURVED PTC IMPLANT, STERILE |
| 18257200092260 | 9W X 27L X 8H, 8DEG CURVED PTC IMPLANT, STERILE |
| 18257200092253 | 9W X 27L X 14H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092246 | 9W X 27L X 13H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092239 | 9W X 27L X 12H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092222 | 9W X 27L X 11H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092215 | 9W X 27L X 10H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092208 | 9W X 27L X 9H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092192 | 9W X 27L X 8H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092185 | 9W X 27L X 7H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092178 | 11W X 31L X 14H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092161 | 11W X 31L X 13H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092154 | 11W X 31L X 12H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092147 | 11W X 31L X 11H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092130 | 11W X 31L X 10H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092123 | 11W X 31L X 9H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092116 | 11W X 31L X 8H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092109 | 11W X 31L X 7H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092093 | 11W X 27L X 14H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092079 | 11W X 27L X 12H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092062 | 11W X 27L X 11H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092055 | 11W X 27L X 10H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092048 | 11W X 27L X 9H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092031 | 11W X 27L X 8H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092024 | 11W X 27L X 7H, 0DEG CURVED PTC IMPLANT, STERILE |
| 18257200092017 | 9W X 27L X 14H, 8DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200092000 | 9W X 27L X 13H, 8DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091997 | 9W X 27L X 12H, 8DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091980 | 9W X 27L X 11H, 8DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091973 | 9W X 27L X 10H, 8DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091966 | 9W X 27L X 9H, 8DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091959 | 9W X 27L X 14H, 0DEG STRAIGH PTC IMPLANT, STERILE |
| 18257200091942 | 9W X 27L X 13H, 0DEG STRAIGH PTC IMPLANT, STERILE |
| 18257200091935 | 9W X 27L X 12H, 0DEG STRAIGH PTC IMPLANT, STERILE |
| 18257200091928 | 9W X 27L X 11H, 0DEG STRAIGH PTC IMPLANT, STERILE |
| 18257200091911 | 9W X 27L X 10H, 0DEG STRAIGH PTC IMPLANT, STERILE |
| 18257200091904 | 9W X 27L X 9H, 0DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091898 | 9W X 27L X 8H, 0DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091881 | 9W X 27L X 7H, 0DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091874 | 11W X 31L X 14H, 0DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091867 | 11W X 31L X 13H, 0DEG STRAIGHT PTC IMPLANT, STERILE |
| 18257200091850 | 11W X 31L X 12H, 0DEG STRAIGHT PTC IMPLANT, STERILE |