| Primary Device ID | 18257200054916 |
| NIH Device Record Key | 1d971338-07c6-41e3-8e78-68d511d695d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SFS |
| Version Model Number | 55-5120 |
| 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 | true |
| 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 | 18257200054916 [Primary] |
| MNI | Orthosis, spinal pedicle fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
[18257200054916]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-27 |
| Device Publish Date | 2019-03-19 |
| 18257200131549 | SFS Tray Kit, Case 1 Instruments and Implants (58-0010) |
| 18257200082049 | SFS CONSIGNMENT OPTION 1 W/ 56 SERIES PEDICLE SCREWS (56-0010) |
| 18257200081493 | SFS RED (59-0010) |
| 18257200081462 | SFS (56-0020) |
| 18257200081455 | SFS (58-0010) |
| 18257200061129 | 4.0MM X 55MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061112 | 4.0MM X 50MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061105 | 4.0MM X 45MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061099 | 4.0MM X 40MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061082 | 4.0MM X 35MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061075 | 4.0MM X 30MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061068 | 4.0MM X 25MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061051 | 4.0MM X 110MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200061044 | 4.0MM X 100MM MONO-AXIAL REDUCTION SCREW, STD |
| 18257200057580 | SFS REDUCTION SCREW CADDY |
| 18257200057573 | SFS REDUCTION SCREW SYSTEM STERILIZATION CASE |
| 18257200057566 | REDUCTION ROD CUTTER |
| 18257200057559 | MULTI-AXIAL REDUCTION SCREWDRIVER REDUCTION PEDICLE SCREW |
| 18257200057542 | MONO-AXIAL REDUCTION SCREWDRIVER REDUCTION PEDICLE SCREW |
| 18257200057535 | TAB REMOVAL TOOL REDUCTION PEDICLE SCREW |
| 18257200057528 | REDUCTION SCREW HEAD ADJUSTER REDUCTION PEDICLE SCREW |
| 18257200057511 | SCALLOPED ANTI SPLAY TOOL REDUCTION PEDICLE SCREW |
| 18257200057504 | ANTI SPLAY TOOL REDUCTION PEDICLE SCREW |
| 18257200056538 | 24MM FIXED CROSS CONNECTOR |
| 18257200056521 | 22MM FIXED CROSS CONNECTOR |
| 18257200056514 | 20MM FIXED CROSS CONNECTOR |
| 18257200056507 | 18MM FIXED CROSS CONNECTOR |
| 18257200056491 | 16MM FIXED CROSS CONNECTOR |
| 18257200056477 | WIDE LUMBAR LAMINAR HOOK SFS HOOK SYSTEM |
| 18257200056460 | NARROW LUMBAR LAMINAR HOOK SFS HOOK SYSTEM |
| 18257200056453 | WIDE THORACIC LAMINAR HOOK SFS HOOK SYSTEM |
| 18257200056446 | NARROW THORACIC LAMINAR HOOK SFS HOOK SYSTEM |
| 18257200056439 | OFFSET RIGHT HOOK SFS HOOK SYSTEM |
| 18257200056422 | OFFSET LEFT HOOK SFS HOOK SYSTEM |
| 18257200056415 | ANGLED RIGHT HOOK SFS HOOK SYSTEM |
| 18257200056408 | ANGLED LEFT HOOK SFS HOOK SYSTEM |
| 18257200056392 | LARGE PEDICLE HOOK SFS HOOK SYSTEM |
| 18257200056385 | SMALL PEDICLE HOOK SFS HOOK SYSTEM |
| 18257200056378 | 600MM ROD WITH HEX ENDS SFS HOOK SYSTEM |
| 18257200056361 | 450MM ROD WITH HEX ENDS SFS HOOK SYSTEM |
| 18257200056354 | SET SCREW SFS HOOK SYSTEM |
| 18257200056347 | SCOLIOSIS INSTRUMENT CASE SFS HOOK SYSTEM #3 |
| 18257200056330 | 23 & 25MM X-CONNECTOR TEMPLATE |
| 18257200056323 | 19 & 21MM X-CONNECTOR TEMPLATE |
| 18257200056316 | 15 & 17MM X-CONNECTOR TEMPLATE |
| 18257200056309 | ROD CLAMP SFS HOOK SYSTEM |
| 18257200056293 | COMBINATION WRENCH, 5MM SFS HOOK SYSTEM |
| 18257200056286 | HOOK SET SCREW TORQUE T-HANDLE 80 LBS/IN, SFS HOOK SYSTEM |
| 18257200056279 | SET SCREW DRIVER/HOLDER SFS HOOK SYSTEM |
| 18257200056262 | BONE AWL SFS HOOK SYSTEM |