Raphael Pedicle Screw System
RAPHAEL™ Polyaxial Reduction Screw, LX, Cannulated, D7.5 x L55mm
11manufacturers in China registered for this device type
61catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | CTL Medical Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K132365 |
| Record published | 2019-10-29 |
| Record revised | 2026-02-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 015.5557 | In distribution | |
| 134.2845 | In distribution | |
| 015.5157 | In distribution | |
| 015.5137 | In distribution | |
| 015.5767 | In distribution | |
| 015.7300 | In distribution | |
| 015.4172 | In distribution | |
| 015.5537 | In distribution | |
| 015.7073 | In distribution | |
| 134.2850 | In distribution | |
| 015.7002 | In distribution | |
| 015.5142 | In distribution | |
| 015.3967 | In distribution | |
| 015.5762 | In distribution | |
| 015.3655 | In distribution | |
| 015.7074 | In distribution | |
| 015.4382 | In distribution | |
| 015.5747 | In distribution | |
| 015.6250 | In distribution | |
| 015.5152 | In distribution | |
| 015.6875 | In distribution | |
| 015.3962 | In distribution | |
| 015.3932 | In distribution | |
| 015.5372 | In distribution | |
| 015.5147 | In distribution | |
| 015.5572 | In distribution | |
| 015.5567 | In distribution | |
| 134.3050 | In distribution | |
| 015.5777 | In distribution | |
| 015.5132 | In distribution | |
| 015.5332 | In distribution | |
| 015.5577 | In distribution | |
| 015.5782 | In distribution | |
| 015.6290 | In distribution | |
| 015.4450 | In distribution | |
| 015.5742 | In distribution | |
| 134.3055 | In distribution | |
| 015.5367 | In distribution | |
| 015.5752 | In distribution | |
| 015.5787 | In distribution | |
| 015.4365 | In distribution | |
| 015.5562 | In distribution | |
| 134.2650 | In distribution | |
| 015.4387 | In distribution | |
| 015.5792 | In distribution | |
| 015.3947 | In distribution | |
| 015.7001 | In distribution | |
| 015.5337 | In distribution | |
| 015.5357 | In distribution | |
| 015.5582 | In distribution | |
| 015.5532 | In distribution | |
| 015.5587 | In distribution | |
| 015.5167 | In distribution | |
| 015.4377 | In distribution | |
| 015.3065 | In distribution | |
| 015.5772 | In distribution | |
| 015.5362 | In distribution | |
| 015.5592 | In distribution | |
| 015.5757 | In distribution | |
| 015.4392 | In distribution | |
| 015.5162 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| CTL Medical Corporation | 510(k) number | 2018-07-05 | Class II | Nonconforming Material/Component | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. i | 133 total devices | 2021-04-28 |
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.