Revere
5.5mm REVERE Threaded HA Uniplanar Reduction Screw, 55mm, Sterile Assembly
13manufacturers in China registered for this device type
997catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K100788 |
| Record published | 2015-10-30 |
| Record revised | 2025-07-02 (version 5) |
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 | Outer diameter 4 to 16 mm; length 8 to 600 mm; width 3.5 to 120 mm; height 6.6 to 20 mm; lumen/inner diameter 8.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 724.912 | Length 125 mm | In distribution |
| 5024.0227S | Length 55 mm | In distribution |
| 1041.5896 | Length 100 mm | In distribution |
| 254.760 | Length 18 mm | In distribution |
| 234.473 | Length 35 mm | In distribution |
| 124.916 | Length 71 mm | In distribution |
| 1041.8609 | Length 65 mm | In distribution |
| 534.356 | Length 50 mm | In distribution |
| 254.854 | Length 12 mm | In distribution |
| 124.244 | Outer Diameter 4.5 mm | In distribution |
| 724.965 | Length 65 mm | In distribution |
| 134.882 | Length 75 mm | In distribution |
| 134.898 | Length 110 mm | In distribution |
| 534.675 | Length 45 mm | In distribution |
| 1041.4504 | Length 40 mm | In distribution |
| 131.356 | Length 50 mm | In distribution |
| 124.185 | Outer Diameter 8.5 mm | In distribution |
| 234.815 | Length 45 mm | In distribution |
| 134.540 | Outer Diameter 6.35 mm | In distribution |
| 124.585 | Outer Diameter 5.5 mm | In distribution |
| 124.420 | Outer Diameter 5.5 mm | In distribution |
| 124.959 | In distribution | |
| 134.216 | Outer Diameter 10 mm | In distribution |
| 1024.0776S | Length 55 mm | In distribution |
| 1041.8927 | Length 65 mm | In distribution |
| 162.361 | Outer Diameter 6.5 mm | In distribution |
| 524.194 | Outer Diameter 10 mm | In distribution |
| 524.897 | Length 110 mm | In distribution |
| 1041.8696 | Length 100 mm | In distribution |
| 1024.0784S | Length 45 mm | In distribution |
| 524.986 | Length 95 mm | In distribution |
| 254.993 | Outer Diameter 5.5 mm | In distribution |
| 234.775 | Outer Diameter 6.5 mm | In distribution |
| 224.091 | Outer Diameter 9 mm | In distribution |
| 234.777 | Length 60 mm | In distribution |
| 1041.8975 | Outer Diameter 8.5 mm | In distribution |
| 162.023 | Length 29.5 mm | In distribution |
| 524.875 | Outer Diameter 7.5 mm | In distribution |
| 524.822 | Outer Diameter 10.5 mm | In distribution |
| 234.197 | Outer Diameter 9 mm | In distribution |
| 234.349 | Outer Diameter 9 mm | In distribution |
| 170.147 | Outer Diameter 4.5 mm | In distribution |
| 134.193 | Length 85 mm | In distribution |
| 224.832 | Outer Diameter 6.5 mm | In distribution |
| 234.416 | Length 400 mm | In distribution |
| 124.474 | Outer Diameter 7.5 mm | In distribution |
| 524.172 | Length 80 mm | In distribution |
| 1041.7680 | Outer Diameter 6.5 mm | In distribution |
| 1024.0086S | Length 95 mm | In distribution |
| 234.146 | Length 50 mm | In distribution |
| 234.997 | Length 150 mm | In distribution |
| 224.481 | Outer Diameter 8.5 mm | In distribution |
| 234.794 | Outer Diameter 9 mm | In distribution |
| 134.224 | Outer Diameter 10 mm | In distribution |
| 1041.5695 | Outer Diameter 6.5 mm | In distribution |
| 5024.0143S | Outer Diameter 7.5 mm | In distribution |
| 1024.0132S | Length 32 mm | In distribution |
| 224.169 | Length 65 mm | In distribution |
| 1024.0252S | Length 30 mm | In distribution |
| 1024.0767S | Outer Diameter 6 mm | In distribution |
| 524.465 | Length 45 mm | In distribution |
| 1024.0454S | Outer Diameter 5.5 mm | In distribution |
| 224.467 | Outer Diameter 6.5 mm | In distribution |
| 5024.0130S | Length 60 mm | In distribution |
| 1041.5420 | Outer Diameter 4.5 mm | In distribution |
| 7041.1500 | Length 500 mm | In distribution |
| 234.706 | Length 50 mm | In distribution |
| 134.228 | Length 110 mm | In distribution |
| 1041.5980 | Length 80 mm | In distribution |
| 124.950 | Width 8.5 mm | In distribution |
| 234.034 | Outer Diameter 8.5 mm | In distribution |
| 124.680 | Outer Diameter 5.5 mm | In distribution |
| 254.620 | Length 15 mm | In distribution |
| 124.234 | Length 85 mm | In distribution |
| 224.712 | Length 30 mm | In distribution |
| 5024.0144S | Length 80 mm | In distribution |
| 234.088 | Length 110 mm | In distribution |
| 234.219 | Length 120 mm | In distribution |
| 1041.5435 | Outer Diameter 4.5 mm | In distribution |
| 234.025 | Outer Diameter 8 mm | In distribution |
| 1041.8815 | Outer Diameter 9.5 mm | In distribution |
| 134.356 | Length 50 mm | In distribution |
| 134.284 | Length 40 mm | In distribution |
| 254.642 | Length 20 mm | In distribution |
| 534.465 | Length 45 mm | In distribution |
| 234.953 | Length 9.25 mm | In distribution |
| 134.086 | Outer Diameter 8.5 mm | In distribution |
| 134.498 | Length 60 mm | In distribution |
| 134.218 | Length 110 mm | In distribution |
| 254.869 | Length 18 mm | In distribution |
| 234.734 | Length 40 mm | In distribution |
| 1041.9853 | Outer Diameter 6.5 mm | In distribution |
| 124.082 | Length 75 mm | In distribution |
| 154.720 | Length 160 mm | In distribution |
| 534.889 | Length 120 mm | In distribution |
| 1041.3795 | Outer Diameter 7.5 mm | In distribution |
| 124.755 | Outer Diameter 7 mm | In distribution |
| 134.407 | Outer Diameter 6.35 mm | In distribution |
| 234.001 | Outer Diameter 6.35 mm | In distribution |
| 124.012 | Length 25 mm | In distribution |
| 162.354 | Outer Diameter 5.5 mm | In distribution |
| 124.203 | Outer Diameter 4 mm | In distribution |
| 124.893 | Length 12 mm | In distribution |
| 254.510 | Length 15 mm | In distribution |
| 131.005 | Height 18 mm | In distribution |
| 124.286 | Outer Diameter 8.5 mm | In distribution |
| 534.469 | Length 65 mm | In distribution |
| 1041.5632 | Length 32 mm | In distribution |
| 5024.0116S | Outer Diameter 5.5 mm | In distribution |
| 124.071 | Outer Diameter 7.5 mm | In distribution |
| 1024.0371S | Length 25 mm | In distribution |
| 534.293 | Outer Diameter 9 mm | In distribution |
| 524.373 | Length 35 mm | In distribution |
| 1041.8972 | Outer Diameter 7 mm | In distribution |
| 1041.3096 | Outer Diameter 10 mm | In distribution |
| 234.265 | Length 45 mm | In distribution |
| 254.500 | Outer Diameter 5.5 mm | In distribution |
| 534.872 | Outer Diameter 7.5 mm | In distribution |
| 1041.3097 | Length 110 mm | In distribution |
| 1024.0783S | Outer Diameter 7 mm | In distribution |
| 524.227 | Length 55 mm | In distribution |
| 5024.0096S | Length 40 mm | In distribution |
| 224.441 | Length 25 mm | In distribution |
| 124.803 | Length 40 mm | In distribution |
| 124.441 | Length 25 mm | In distribution |
| 1041.4730 | Length 30 mm | In distribution |
| 254.671 | Outer Diameter 6.35 mm | In distribution |
| 1024.0785S | Length 50 mm | In distribution |
| 224.991 | Length 20 mm | In distribution |
| 254.955 | Length 200 mm | In distribution |
| 231.007 | Height 20 mm | In distribution |
| 234.074 | Length 85 mm | In distribution |
| 1041.8963 | Outer Diameter 7 mm | In distribution |
| 134.893 | Length 80 mm | In distribution |
| 124.915 | Length 48 mm | In distribution |
| 124.223 | Outer Diameter 9 mm | In distribution |
| 170.051 | Outer Diameter 5 mm | In distribution |
| 524.643 | Outer Diameter 4.5 mm | In distribution |
| 1041.8106 | Outer Diameter 6 mm | In distribution |
| 224.144 | Outer Diameter 5.5 mm | In distribution |
| 1041.0300 | Outer Diameter 4.5 mm | In distribution |
| 224.054 | Length 40 mm | In distribution |
| 524.806 | Outer Diameter 8.5 mm | In distribution |
| 1041.3440 | Length 40 mm | In distribution |
| 234.441 | Length 25 mm | In distribution |
| 234.942 | Length 10 mm | In distribution |
| 224.883 | Length 80 mm | In distribution |
| 134.471 | Outer Diameter 7.5 mm | In distribution |
| 134.782 | Outer Diameter 7 mm | In distribution |
| 1024.0057S | Length 55 mm | In distribution |
| 224.814 | Length 40 mm | In distribution |
| 234.803 | Length 35 mm | In distribution |
| 1041.7508 | Outer Diameter 5 mm | In distribution |
| 234.187 | Length 55 mm | In distribution |
| 124.963 | Width 12 mm | In distribution |
| 734.408 | Outer Diameter 6.35 mm | In distribution |
| 134.751 | Outer Diameter 7 mm | In distribution |
| 134.852 | Length 30 mm | In distribution |
| 524.287 | Length 55 mm | In distribution |
| 1041.5070 | Length 70 mm | In distribution |
| 534.355 | Length 45 mm | In distribution |
| 162.021 | Length 28.5 mm | In distribution |
| 234.068 | Length 60 mm | In distribution |
| 134.367 | Length 55 mm | In distribution |
| 534.651 | Length 25 mm | In distribution |
| 224.881 | Length 70 mm | In distribution |
| 1041.7785 | Length 85 mm | In distribution |
| 162.462 | Length 32 mm | In distribution |
| 5024.0162S | Length 30 mm | In distribution |
| 234.936 | Length 10.5 mm | In distribution |
| 234.805 | Length 45 mm | In distribution |
| 534.891 | Length 70 mm | In distribution |
| 234.043 | Outer Diameter 9 mm | In distribution |
| 524.118 | Length 40 mm | In distribution |
| 1024.0432S | Outer Diameter 4 mm | In distribution |
| 224.267 | Outer Diameter 6.5 mm | In distribution |
| 1041.9321 | Length 20 mm | In distribution |
| 234.262 | Outer Diameter 6.5 mm | In distribution |
| 1041.5437 | Outer Diameter 4.5 mm | In distribution |
| 154.851 | Outer Diameter 5.5 mm | In distribution |
| 224.473 | Length 35 mm | In distribution |
| 124.982 | Length 33 mm | In distribution |
| 134.496 | Outer Diameter 9 mm | In distribution |
| 231.002 | Height 14 mm | In distribution |
| 131.212 | Outer Diameter 13 mm | In distribution |
| 124.279 | Length 65 mm | In distribution |
| 134.758 | Outer Diameter 7 mm | In distribution |
| 1041.8980 | Length 30 mm | In distribution |
| 224.153 | Length 35 mm | In distribution |
| 1041.7898 | Outer Diameter 8.5 mm | In distribution |
| 1024.0378S | Outer Diameter 7.5 mm | In distribution |
| 524.980 | Outer Diameter 7 mm | In distribution |
| 134.856 | Length 50 mm | In distribution |
| 224.281 | Length 25 mm | In distribution |
| 134.482 | Length 30 mm | In distribution |
| 524.217 | Outer Diameter 5 mm | In distribution |
| 524.837 | Outer Diameter 6 mm | In distribution |
| 524.231 | Length 25 mm | In distribution |
| 234.464 | Length 40 mm | In distribution |
| 534.268 | Length 60 mm | In distribution |
| 234.883 | Length 80 mm | In distribution |
| 524.675 | Length 45 mm | In distribution |
| 234.299 | Outer Diameter 9 mm | In distribution |
| 170.267 | Outer Diameter 6.5 mm | In distribution |
| 1024.0106S | Length 50 mm | In distribution |
| 534.377 | Length 55 mm | In distribution |
| 534.484 | Length 40 mm | In distribution |
| 534.644 | Length 40 mm | In distribution |
| 1041.9215 | Length 120 mm | In distribution |
| 134.106 | Outer Diameter 10 mm | In distribution |
| 1041.6020 | Outer Diameter 10 mm | In distribution |
| 134.885 | Outer Diameter 8.5 mm | In distribution |
| 534.262 | Outer Diameter 6.5 mm | In distribution |
| 1041.4998 | Length 120 mm | In distribution |
| 1041.9514 | Length 350 mm | In distribution |
| 124.384 | Length 40 mm | In distribution |
| 224.431 | Length 25 mm | In distribution |
| 734.980 | Outer Diameter 6.35 mm | In distribution |
| 224.072 | Outer Diameter 7.5 mm | In distribution |
| 134.929 | Height 8.5 mm | In distribution |
| 124.235 | Length 90 mm | In distribution |
| 154.003 | Length 20 mm | In distribution |
| 254.851 | Length 200 mm | In distribution |
| 224.457 | Outer Diameter 5.5 mm | In distribution |
| 1041.8265 | Length 65 mm | In distribution |
| 7041.0070 | Length 70 mm | In distribution |
| 1041.9195 | Length 70 mm | In distribution |
| 1041.4825 | Length 25 mm | In distribution |
| 254.022 | Outer Diameter 6 mm | In distribution |
| 234.560 | Outer Diameter 6.35 mm | In distribution |
| 124.974 | Width 120 mm | In distribution |
| 1041.2055 | Length 55 mm | In distribution |
| 124.200 | Length 20 mm | In distribution |
| 124.488 | Outer Diameter 8.5 mm | In distribution |
| 162.372 | Length 30 mm | In distribution |
| 1041.3895 | Length 95 mm | In distribution |
| 524.152 | Outer Diameter 8.5 mm | In distribution |
| 234.176 | Outer Diameter 7.5 mm | In distribution |
| 224.244 | Outer Diameter 4.5 mm | In distribution |
| 534.896 | Length 95 mm | In distribution |
| 524.009 | Length 500 mm | In distribution |
| 234.519 | Length 300 mm | In distribution |
| 224.927 | Length 9.5 mm | In distribution |
| 170.242 | Outer Diameter 4.5 mm | In distribution |
| 231.203 | Outer Diameter 16 mm | In distribution |
| 124.486 | Length 50 mm | In distribution |
| 134.924 | In distribution | |
| 134.357 | Outer Diameter 5.5 mm | In distribution |
| 1024.0752S | Outer Diameter 7 mm | In distribution |
| 134.655 | Outer Diameter 6.35 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
| Polaris 5.5 Spinal System | Biomet Spine | 707 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K040442 | 2004-05-20 |
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.