Rhausler
Bicortical Self Tapping Locking Screws,4.0x18mm,Silver, Single Use Only
14manufacturers in China registered for this device type
152catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Rhausler, Inc., United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K042073 |
| Record published | 2024-03-11 |
| Record revised | 2025-11-20 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 2 to 109 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C-7030 | Length 12 mm | In distribution |
| C-7040 | Length 3 mm | In distribution |
| C-5473 | Length 69 mm | In distribution |
| C-6116 | Length 16 mm | In distribution |
| C-4366 | Length 66 mm | In distribution |
| C-4354 | Length 54 mm | In distribution |
| C-5375 | Length 72 mm | In distribution |
| C-3375 | Length 75 mm | In distribution |
| C-5485 | Length 81 mm | In distribution |
| C-5493 | Length 89 mm | In distribution |
| C-5133 | Length 33 mm | In distribution |
| C-6401 | In distribution | |
| C-4252 | Length 52 mm | In distribution |
| C-4133 | Length 33 mm | In distribution |
| C-5121 | Length 21 mm | In distribution |
| C-4473 | Length 73 mm | In distribution |
| C-7053-10 | Length 10 mm | In distribution |
| C-5477 | Length 73 mm | In distribution |
| C-7010 | In distribution | |
| C-7042 | Length 19 mm | In distribution |
| C-6400 | In distribution | |
| C-7026 | In distribution | |
| C-4131 | Length 31 mm | In distribution |
| C-7044 | Length 18 mm | In distribution |
| C-4372 | Length 72 mm | In distribution |
| C-3123 | Length 23 mm | In distribution |
| C-5497 | Length 93 mm | In distribution |
| C-5369 | Length 66 mm | In distribution |
| C-5240 | Length 37 mm | In distribution |
| C-3125 | Length 25 mm | In distribution |
| C-3243 | Length 43 mm | In distribution |
| C-7039 | Length 12 mm | In distribution |
| C-6012 | Length 12 mm | In distribution |
| C-3131 | Length 31 mm | In distribution |
| C-3378 | Length 78 mm | In distribution |
| C-7019 | Length 10 mm | In distribution |
| C-4378 | Length 78 mm | In distribution |
| C-5469 | Length 78 mm | In distribution |
| C-3255 | Length 55 mm | In distribution |
| C-6005 | Length 109 mm | In distribution |
| C-4369 | Length 69 mm | In distribution |
| C-4505 | Length 105 mm | In distribution |
| C-5378 | Length 75 mm | In distribution |
| C-7025 | In distribution | |
| C-5481 | Length 77 mm | In distribution |
| C-3363 | Length 63 mm | In distribution |
| C-3372 | Length 72 mm | In distribution |
| C-6212 | Length 12 mm | In distribution |
| C-7007 | In distribution | |
| C-7053-14 | Length 14 mm | In distribution |
| C-3366 | Length 66 mm | In distribution |
| C-5252 | Length 49 mm | In distribution |
| C-4469 | Length 69 mm | In distribution |
| C-7035 | In distribution | |
| C-3129 | Length 29 mm | In distribution |
| C-7015 | In distribution | |
| C-4123 | Length 23 mm | In distribution |
| C-5354 | Length 55 mm | In distribution |
| C-5131 | Length 31 mm | In distribution |
| C-7047 | In distribution | |
| C-4481 | Length 81 mm | In distribution |
| C-7045 | Length 2 mm | In distribution |
| C-6322 | Length 22 mm | In distribution |
| C-5366 | Length 63 mm | In distribution |
| C-5489 | Length 85 mm | In distribution |
| C-3240 | Length 40 mm | In distribution |
| C-3135 | Length 35 mm | In distribution |
| C-5363 | Length 60 mm | In distribution |
| C-7056 | In distribution | |
| C-4375 | Length 75 mm | In distribution |
| C-5505 | Length 101 mm | In distribution |
| C-5372 | Length 69 mm | In distribution |
| C-7033 | Length 3 mm | In distribution |
| C-5123 | Length 23 mm | In distribution |
| C-7041 | Length 16 mm | In distribution |
| C-5509 | Length 105 mm | In distribution |
| C-4125 | Length 25 mm | In distribution |
| C-3133 | Length 33 mm | In distribution |
| C-7012 | In distribution | |
| C-4237 | Length 37 mm | In distribution |
| C-6214 | Length 14 mm | In distribution |
| C-5246 | Length 43 mm | In distribution |
| C-3121 | Length 21 mm | In distribution |
| C-7038 | Length 14 mm | In distribution |
| C-4363 | Length 63 mm | In distribution |
| C-4129 | Length 29 mm | In distribution |
| C-5243 | Length 40 mm | In distribution |
| C-3237 | Length 37 mm | In distribution |
| C-4493 | Length 93 mm | In distribution |
| C-7028 | In distribution | |
| C-7052 | In distribution | |
| C-7053-18 | Length 18 mm | In distribution |
| C-3249 | Length 49 mm | In distribution |
| C-5357 | Length 54 mm | In distribution |
| C-5125 | Length 25 mm | In distribution |
| C-7055 | In distribution | |
| C-4357 | Length 57 mm | In distribution |
| C-3246 | Length 46 mm | In distribution |
| C-7053-12 | Length 12 mm | In distribution |
| C-4477 | Length 77 mm | In distribution |
| C-4509 | Length 109 mm | In distribution |
| C-5129 | Length 29 mm | In distribution |
| C-5501 | Length 97 mm | In distribution |
| C-4489 | Length 89 mm | In distribution |
| C-7053 | In distribution | |
| C-3252 | Length 52 mm | In distribution |
| C-6010 | Length 10 mm | In distribution |
| C-5127 | Length 27 mm | In distribution |
| C-6112 | Length 12 mm | In distribution |
| C-7053-20 | Length 20 mm | In distribution |
| C-6216 | Length 16 mm | In distribution |
| C-7053-16 | Length 16 mm | In distribution |
| C-6318 | Length 18 mm | In distribution |
| C-4501 | Length 101 mm | In distribution |
| C-7043 | Length 16 mm | In distribution |
| C-3354 | Length 54 mm | In distribution |
| C-5135 | Length 35 mm | In distribution |
| C-4485 | Length 85 mm | In distribution |
| C-6110 | Length 10 mm | In distribution |
| C-6014 | Length 14 mm | In distribution |
| C-5237 | Length 16 mm | In distribution |
| C-6320 | Length 20 mm | In distribution |
| C-7031 | In distribution | |
| C-4240 | Length 40 mm | In distribution |
| C-4121 | Length 21 mm | In distribution |
| C-7036 | In distribution | |
| C-4127 | Length 27 mm | In distribution |
| C-7046 | In distribution | |
| C-4255 | Length 55 mm | In distribution |
| C-3360 | Length 60 mm | In distribution |
| C-7050 | In distribution | |
| C-3357 | Length 57 mm | In distribution |
| C-7051 | In distribution | |
| C-4135 | Length 35 mm | In distribution |
| C-6118 | Length 18 mm | In distribution |
| C-5249 | Length 46 mm | In distribution |
| C-3127 | Length 27 mm | In distribution |
| C-4243 | Length 43 mm | In distribution |
| C-4249 | Length 49 mm | In distribution |
| C-4246 | Length 46 mm | In distribution |
| C-4360 | Length 60 mm | In distribution |
| C-6016 | Length 16 mm | In distribution |
| C-7049 | In distribution | |
| C-5255 | Length 52 mm | In distribution |
| C-7034 | Length 14 mm | In distribution |
| C-5360 | Length 57 mm | In distribution |
| C-6210 | Length 10 mm | In distribution |
| C-7048 | In distribution | |
| C-4497 | Length 97 mm | In distribution |
| C-6114 | Length 14 mm | In distribution |
| C-6120 | Length 20 mm | In distribution |
| C-3369 | Length 69 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
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.