Fortify
FORTIFYâ¿¢ I -R 14mm Core, Height 27-34mm, 14x14mm Footprint, 0°, No Spikes
3manufacturers in China registered for this device type
866catalogue numbers in this listing
11510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K112756 |
| Record published | 2016-02-13 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Depth 12 to 25 mm; width 12 to 60 mm; height 15 to 99 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 151.981 | Depth 18 mm | In distribution |
| 137.361 | Depth 14 mm | In distribution |
| 137.480 | Width 30 mm | In distribution |
| 137.885 | Width 30 mm | In distribution |
| 137.950 | Width 40 mm | In distribution |
| 337.101 | Width 23 mm | In distribution |
| 151.701S | In distribution | |
| 151.103 | Width 16 mm | In distribution |
| 337.310 | Width 16 mm | In distribution |
| 137.932 | Depth 22 mm | In distribution |
| 151.370 | Width 14 mm | In distribution |
| 137.731 | Depth 16 mm | In distribution |
| 337.031 | Height 31 mm | In distribution |
| 351.053 | Height 49 mm | In distribution |
| 137.831 | Sagittal Profile 4 Degree | In distribution |
| 151.971 | Depth 18 mm | In distribution |
| 151.443 | Depth 20 mm | In distribution |
| 337.752 | Sagittal Profile 7 Degree | In distribution |
| 137.752 | Sagittal Profile 7 Degree | In distribution |
| 151.515 | Depth 18 mm | In distribution |
| 137.660 | Width 45 mm | In distribution |
| 337.711 | Depth 14 mm | In distribution |
| 351.050 | Depth 14 mm | In distribution |
| 151.755 | Width 16 mm | In distribution |
| 151.571 | Width 20 mm | In distribution |
| 151.811 | Depth 16 mm | In distribution |
| 337.411 | Depth 21 mm | In distribution |
| 151.605 | Width 40 mm | In distribution |
| 151.435 | Width 30 mm | In distribution |
| 151.601 | Width 40 mm | In distribution |
| 137.672 | Depth 22 mm | In distribution |
| 137.983 | Sagittal Profile 12 Degree | In distribution |
| 151.645 | Width 60 mm | In distribution |
| 337.229 | Height 29 mm | In distribution |
| 337.332 | Sagittal Profile 7 Degree | In distribution |
| 351.454 | Sagittal Profile 8 Degree | In distribution |
| 351.325 | Depth 15 mm | In distribution |
| 137.481 | Depth 25 mm | In distribution |
| 137.464 | Width 23 mm | In distribution |
| 137.733 | Sagittal Profile 10 Degree | In distribution |
| 151.980 | Depth 18 mm | In distribution |
| 337.801 | Height 30 mm | In distribution |
| 151.381 | Width 18 mm | In distribution |
| 351.383 | Depth 16 mm | In distribution |
| 337.023 | Width 14 mm | In distribution |
| 351.332 | Width 20 mm | In distribution |
| 137.990 | Depth 22 mm | In distribution |
| 151.350 | Depth 12 mm | In distribution |
| 337.730 | Depth 16 mm | In distribution |
| 151.323S | In distribution | |
| 337.383 | Depth 16 mm | In distribution |
| 337.001 | Height 25 mm | In distribution |
| 337.363 | Depth 14 mm | In distribution |
| 137.611 | Sagittal Profile 4 Degree | In distribution |
| 137.002 | Depth 12 mm | In distribution |
| 151.483 | Depth 25 mm | In distribution |
| 151.053 | Height 25 mm | In distribution |
| 337.413 | Width 23 mm | In distribution |
| 351.416 | Sagittal Profile 16 Degree | In distribution |
| 137.302 | Sagittal Profile 7 Degree | In distribution |
| 137.381 | Sagittal Profile 3.5 Degree | In distribution |
| 137.001 | Width 14 mm | In distribution |
| 337.460 | Depth 21 mm | In distribution |
| 351.360 | Depth 14 mm | In distribution |
| 137.662 | Width 45 mm | In distribution |
| 151.565 | Sagittal Profile 12 Degree | In distribution |
| 151.884 | Depth 16 mm | In distribution |
| 151.587 | Width 22 mm | In distribution |
| 151.343 | Depth 16 mm | In distribution |
| 151.641 | Width 60 mm | In distribution |
| 151.583 | Depth 18 mm | In distribution |
| 337.301 | Depth 14 mm | In distribution |
| 151.554 | Depth 16 mm | In distribution |
| 337.353 | Width 14 mm | In distribution |
| 137.813 | Width 23 mm | In distribution |
| 337.864 | Sagittal Profile 16 Degree | In distribution |
| 337.037 | Depth 12 mm | In distribution |
| 337.463 | Depth 21 mm | In distribution |
| 151.524 | Width 20 mm | In distribution |
| 151.964 | Sagittal Profile 8 Degree | In distribution |
| 151.602 | Depth 22 mm | In distribution |
| 151.465 | Depth 21 mm | In distribution |
| 351.372 | Depth 15 mm | In distribution |
| 151.363 | Depth 14 mm | In distribution |
| 151.500 | Depth 16 mm | In distribution |
| 351.007 | Sagittal Profile 3.5 Degree | In distribution |
| 337.231 | Width 14 mm | In distribution |
| 151.704S | In distribution | |
| 151.153 | Depth 20 mm | In distribution |
| 337.860 | Width 23 mm | In distribution |
| 151.633 | Depth 22 mm | In distribution |
| 137.382 | Sagittal Profile 7 Degree | In distribution |
| 151.974 | Depth 18 mm | In distribution |
| 151.450 | Depth 20 mm | In distribution |
| 337.243 | Depth 12 mm | In distribution |
| 137.353 | Sagittal Profile 10 Degree | In distribution |
| 137.962 | Depth 22 mm | In distribution |
| 151.405 | Width 20 mm | In distribution |
| 137.312 | Sagittal Profile 7 Degree | In distribution |
| 137.940 | Width 60 mm | In distribution |
| 351.365 | Depth 14 mm | In distribution |
| 351.480 | Depth 25 mm | In distribution |
| 151.812 | Width 35 mm | In distribution |
| 151.810 | Depth 16 mm | In distribution |
| 151.334 | Depth 15 mm | In distribution |
| 151.552 | Sagittal Profile 4 Degree | In distribution |
| 151.310 | Width 14 mm | In distribution |
| 151.535 | Depth 18 mm | In distribution |
| 151.703 | Width 16 mm | In distribution |
| 351.470 | Depth 22 mm | In distribution |
| 351.436 | Width 30 mm | In distribution |
| 137.883 | Width 30 mm | In distribution |
| 137.963 | Width 45 mm | In distribution |
| 337.331 | Sagittal Profile 3.5 Degree | In distribution |
| 137.411 | Sagittal Profile 4 Degree | In distribution |
| 151.671 | Width 50 mm | In distribution |
| 151.921 | Depth 18 mm | In distribution |
| 351.450 | Width 20 mm | In distribution |
| 151.563 | Depth 18 mm | In distribution |
| 337.002 | Sagittal Profile 3.5 Degree | In distribution |
| 137.701 | Width 14 mm | In distribution |
| 137.482 | Depth 25 mm | In distribution |
| 151.612 | Width 45 mm | In distribution |
| 351.380 | Depth 16 mm | In distribution |
| 151.364 | Sagittal Profile 7 Degree | In distribution |
| 351.315 | Width 16 mm | In distribution |
| 337.045 | Depth 12 mm | In distribution |
| 151.001S | In distribution | |
| 151.480 | Width 30 mm | In distribution |
| 137.642 | Depth 22 mm | In distribution |
| 151.345 | Sagittal Profile 10 Degree | In distribution |
| 151.642 | Depth 22 mm | In distribution |
| 151.883 | Depth 16 mm | In distribution |
| 351.314 | Sagittal Profile 7 Degree | In distribution |
| 151.561 | Depth 18 mm | In distribution |
| 337.783 | Width 20 mm | In distribution |
| 151.682 | Sagittal Profile 4 Degree | In distribution |
| 351.054 | Width 14 mm | In distribution |
| 351.452 | Depth 20 mm | In distribution |
| 151.580 | Depth 18 mm | In distribution |
| 337.482 | Depth 25 mm | In distribution |
| 151.051 | Height 19 mm | In distribution |
| 151.324 | Depth 12 mm | In distribution |
| 151.931 | Width 45 mm | In distribution |
| 151.610 | Width 45 mm | In distribution |
| 337.139 | Depth 12 mm | In distribution |
| 151.413 | Depth 21 mm | In distribution |
| 151.904 | Depth 18 mm | In distribution |
| 137.761 | Sagittal Profile 3.5 Degree | In distribution |
| 351.415 | Depth 21 mm | In distribution |
| 151.863 | Depth 16 mm | In distribution |
| 151.520 | Depth 16 mm | In distribution |
| 151.496 | Width 35 mm | In distribution |
| 351.463 | Depth 21 mm | In distribution |
| 151.705 | Width 16 mm | In distribution |
| 151.851 | Width 30 mm | In distribution |
| 351.333 | Depth 16 mm | In distribution |
| 151.534 | Sagittal Profile 8 Degree | In distribution |
| 151.702 | Width 16 mm | In distribution |
| 337.751 | Width 14 mm | In distribution |
| 351.305 | Sagittal Profile 10 Degree | In distribution |
| 137.681 | Depth 22 mm | In distribution |
| 151.913 | Width 35 mm | In distribution |
| 151.445 | Depth 20 mm | In distribution |
| 337.117 | Depth 12 mm | In distribution |
| 151.825 | Sagittal Profile 12 Degree | In distribution |
| 351.451 | Depth 20 mm | In distribution |
| 337.215 | Sagittal Profile 7 Degree | In distribution |
| 351.320 | Width 18 mm | In distribution |
| 151.411 | Width 23 mm | In distribution |
| 337.763 | Sagittal Profile 10 Degree | In distribution |
| 151.474 | Depth 22 mm | In distribution |
| 351.352 | Depth 14 mm | In distribution |
| 151.315 | Width 14 mm | In distribution |
| 137.980 | Width 55 mm | In distribution |
| 651.070 | In distribution | |
| 151.652 | Width 40 mm | In distribution |
| 151.661 | Width 45 mm | In distribution |
| 351.422 | Depth 22 mm | In distribution |
| 151.420 | Depth 22 mm | In distribution |
| 151.803 | Width 30 mm | In distribution |
| 351.002 | Height 17 mm | In distribution |
| 337.430 | Width 30 mm | In distribution |
| 151.651 | Width 40 mm | In distribution |
| 151.220 | Width 20 mm | In distribution |
| 337.410 | Depth 21 mm | In distribution |
| 137.410 | Depth 21 mm | In distribution |
| 151.464 | Depth 21 mm | In distribution |
| 151.932 | Sagittal Profile 4 Degree | In distribution |
| 351.435 | Depth 25 mm | In distribution |
| 151.414 | Sagittal Profile 8 Degree | In distribution |
| 151.695 | Sagittal Profile 12 Degree | In distribution |
| 351.301 | Width 14 mm | In distribution |
| 351.010 | Width 14 mm | In distribution |
| 137.865 | Width 23 mm | In distribution |
| 151.600 | Width 40 mm | In distribution |
| 337.041 | Width 14 mm | In distribution |
| 337.832 | Width 30 mm | In distribution |
| 337.303 | Depth 14 mm | In distribution |
| 151.052S | In distribution | |
| 151.333S | In distribution | |
| 151.611 | Width 45 mm | In distribution |
| 151.983 | Sagittal Profile 4 Degree | In distribution |
| 337.811 | Sagittal Profile 4 Degree | In distribution |
| 151.625 | Sagittal Profile 12 Degree | In distribution |
| 151.860 | Depth 16 mm | In distribution |
| 137.621 | Width 50 mm | In distribution |
| 351.310 | Width 16 mm | In distribution |
| 151.492 | Depth 20 mm | In distribution |
| 151.630 | Depth 22 mm | In distribution |
| 337.351 | Width 14 mm | In distribution |
| 337.432 | Width 30 mm | In distribution |
| 151.455 | Sagittal Profile 12 Degree | In distribution |
| 151.933 | Width 45 mm | In distribution |
| 137.901 | Sagittal Profile 4 Degree | In distribution |
| 151.801 | Depth 16 mm | In distribution |
| 137.933 | Sagittal Profile 12 Degree | In distribution |
| 137.009 | Height 23 mm | In distribution |
| 137.702 | Width 14 mm | In distribution |
| 137.753 | Depth 12 mm | In distribution |
| 137.703 | Depth 12 mm | In distribution |
| 351.052 | Depth 14 mm | In distribution |
| 137.331 | Sagittal Profile 3.5 Degree | In distribution |
| 151.522 | Sagittal Profile 4 Degree | In distribution |
| 151.861 | Width 35 mm | In distribution |
| 151.466 | Width 23 mm | In distribution |
| 151.572 | Depth 16 mm | In distribution |
| 151.675 | Depth 22 mm | In distribution |
| 151.925 | Width 40 mm | In distribution |
| 151.311 | Depth 14 mm | In distribution |
| 337.302 | Sagittal Profile 7 Degree | In distribution |
| 151.512 | Width 18 mm | In distribution |
| 151.321 | Depth 12 mm | In distribution |
| 151.150 | Width 20 mm | In distribution |
| 151.055S | In distribution | |
| 137.483 | Depth 25 mm | In distribution |
| 151.152 | Width 20 mm | In distribution |
| 151.553 | Sagittal Profile 4 Degree | In distribution |
| 151.850 | Width 30 mm | In distribution |
| 337.713 | Depth 14 mm | In distribution |
| 137.432 | Depth 25 mm | In distribution |
| 137.992 | Width 60 mm | In distribution |
| 151.962 | Depth 18 mm | In distribution |
| 351.467 | Width 23 mm | In distribution |
| 337.333 | Depth 16 mm | In distribution |
| 351.430 | Depth 25 mm | In distribution |
| 337.710 | Width 16 mm | In distribution |
| 151.353 | Depth 12 mm | In distribution |
| 137.712 | Depth 14 mm | In distribution |
| 151.635 | Sagittal Profile 12 Degree | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
| Novel Spinal Spacer System | Alphatec Spine, Inc. | 340 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190147 | 2019-05-08 |
| K173982 | 2018-09-19 |
| K162315 | 2017-11-09 |
| K121107 | 2012-07-03 |
| K112756 | 2011-10-07 |
| K072465 | 2007-10-04 |
| K061380 | 2006-06-08 |
| K060665 | 2006-05-10 |
| K050850 | 2005-05-26 |
| K040284 | 2004-03-23 |
| K031302 | 2003-06-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.