Raphael Pedicle Screw System
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13manufacturers in China registered for this device type
262catalogue numbers in this listing
1recall
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, Spinal Pedicle Fixation
Record
| Listed by | CTL Medical Corporation, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K132365 |
| Record published | 2017-08-08 |
| Record revised | 2026-02-19 (version 8) |
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 |
|---|---|---|
| 015.4842 | In distribution | |
| 015.5130 | In distribution | |
| 015.5330 | In distribution | |
| 015.2830 | In distribution | |
| 015.3237 | In distribution | |
| 015.5060 | In distribution | |
| 015.3642 | In distribution | |
| 015.4345 | In distribution | |
| 015.1010 | In distribution | |
| 015.5545 | In distribution | |
| 015.5540 | In distribution | |
| 015.3245 | In distribution | |
| 015.6070 | In distribution | |
| 015.3037 | In distribution | |
| 015.6900 | In distribution | |
| 015.4547 | In distribution | |
| 015.5062 | In distribution | |
| 015.3650 | In distribution | |
| 015.3687 | In distribution | |
| 015.4150 | In distribution | |
| 015.5347 | In distribution | |
| 015.4642 | In distribution | |
| 015.4647 | In distribution | |
| 015.3637 | In distribution | |
| 015.3232 | In distribution | |
| 015.3442 | In distribution | |
| 015.4862 | In distribution | |
| 015.3252 | In distribution | |
| 015.6840 | In distribution | |
| 015.3950 | In distribution | |
| 015.2837 | In distribution | |
| 015.4832 | In distribution | |
| 015.3648 | In distribution | |
| 015.3957 | In distribution | |
| 015.2840 | In distribution | |
| 015.4837 | In distribution | |
| 015.6120 | In distribution | |
| 015.6850 | In distribution | |
| 015.4135 | In distribution | |
| 015.5335 | In distribution | |
| 015.3942 | In distribution | |
| 015.4835 | In distribution | |
| 015.3055 | In distribution | |
| 015.5547 | In distribution | |
| 015.6125 | In distribution | |
| 015.4142 | In distribution | |
| 015.5140 | In distribution | |
| 015.2832 | In distribution | |
| 015.5355 | In distribution | |
| 015.3668 | In distribution | |
| 015.5352 | In distribution | |
| 015.3937 | In distribution | |
| 015.3647 | In distribution | |
| 015.4147 | In distribution | |
| 015.3667 | In distribution | |
| 015.7200 | In distribution | |
| 015.4662 | In distribution | |
| 015.6150 | In distribution | |
| 015.3955 | In distribution | |
| 015.3633 | In distribution | |
| 015.3460 | In distribution | |
| 015.3945 | In distribution | |
| 015.4865 | In distribution | |
| 015.5555 | In distribution | |
| 015.5135 | In distribution | |
| 015.3052 | In distribution | |
| 015.3940 | In distribution | |
| 015.2842 | In distribution | |
| 015.4667 | In distribution | |
| 015.6055 | In distribution | |
| 015.3653 | In distribution | |
| 015.4130 | In distribution | |
| 015.3487 | In distribution | |
| 015.4855 | In distribution | |
| 015.4872 | In distribution | |
| 015.4857 | In distribution | |
| 015.2827 | In distribution | |
| 015.2850 | In distribution | |
| 015.6095 | In distribution | |
| 015.3657 | In distribution | |
| 015.5087 | In distribution | |
| 015.4132 | In distribution | |
| 015.4850 | In distribution | |
| 015.3540 | In distribution | |
| 015.6140 | In distribution | |
| 015.5037 | In distribution | |
| 015.3455 | In distribution | |
| 015.3272 | In distribution | |
| 015.6860 | In distribution | |
| 015.3663 | In distribution | |
| 015.3437 | In distribution | |
| 015.3260 | In distribution | |
| 015.6040 | In distribution | |
| 015.5542 | In distribution | |
| 015.4552 | In distribution | |
| 015.5067 | In distribution | |
| 015.4645 | In distribution | |
| 015.4655 | In distribution | |
| 015.6890 | In distribution | |
| 015.3030 | In distribution | |
| 015.4665 | In distribution | |
| 015.4660 | In distribution | |
| 015.3555 | In distribution | |
| 015.4355 | In distribution | |
| 015.3050 | In distribution | |
| 015.4650 | In distribution | |
| 015.4845 | In distribution | |
| 015.4140 | In distribution | |
| 015.5340 | In distribution | |
| 015.3635 | In distribution | |
| 015.6085 | In distribution | |
| 015.3462 | In distribution | |
| 015.6090 | In distribution | |
| 015.4542 | In distribution | |
| 015.4360 | In distribution | |
| 015.4137 | In distribution | |
| 015.3045 | In distribution | |
| 015.3692 | In distribution | |
| 015.4847 | In distribution | |
| 015.6065 | In distribution | |
| 015.5552 | In distribution | |
| 015.3267 | In distribution | |
| 015.4630 | In distribution | |
| 015.3638 | In distribution | |
| 015.2857 | In distribution | |
| 015.5345 | In distribution | |
| 015.6030 | In distribution | |
| 015.2855 | In distribution | |
| 015.3482 | In distribution | |
| 015.4160 | In distribution | |
| 015.6060 | In distribution | |
| 015.3452 | In distribution | |
| 015.3047 | In distribution | |
| 015.4640 | In distribution | |
| 015.3673 | In distribution | |
| 015.3677 | In distribution | |
| 015.7000 | In distribution | |
| 015.3682 | In distribution | |
| 015.6880 | In distribution | |
| 015.3262 | In distribution | |
| 015.5052 | In distribution | |
| 015.4852 | In distribution | |
| 015.2862 | In distribution | |
| 015.3255 | In distribution | |
| 015.3067 | In distribution | |
| 015.6080 | In distribution | |
| 015.4165 | In distribution | |
| 015.3062 | In distribution | |
| 015.3688 | In distribution | |
| 015.3643 | In distribution | |
| 015.3250 | In distribution | |
| 015.2847 | In distribution | |
| 015.3535 | In distribution | |
| 015.3235 | In distribution | |
| 015.6050 | In distribution | |
| 015.6865 | In distribution | |
| 015.4157 | In distribution | |
| 015.4652 | In distribution | |
| 015.6925 | In distribution | |
| 015.3693 | In distribution | |
| 015.6830 | In distribution | |
| 015.5035 | In distribution | |
| 015.3662 | In distribution | |
| 015.5032 | In distribution | |
| 015.6870 | In distribution | |
| 015.4867 | In distribution | |
| 015.4830 | In distribution | |
| 015.3265 | In distribution | |
| 015.5050 | In distribution | |
| 015.3640 | In distribution | |
| 015.2835 | In distribution | |
| 015.6910 | In distribution | |
| 015.3445 | In distribution | |
| 015.3678 | In distribution | |
| 015.5535 | In distribution | |
| 015.3930 | In distribution | |
| 015.3935 | In distribution | |
| 015.5350 | In distribution | |
| 015.5030 | In distribution | |
| 015.4537 | In distribution | |
| 015.2860 | In distribution | |
| 015.4635 | In distribution | |
| 015.6920 | In distribution | |
| 015.6035 | In distribution | |
| 015.4860 | In distribution | |
| 015.3230 | In distribution | |
| 015.6130 | In distribution | |
| 015.3447 | In distribution | |
| 015.6110 | In distribution | |
| 015.3645 | In distribution | |
| 015.4632 | In distribution | |
| 015.6845 | In distribution | |
| 015.3440 | In distribution | |
| 015.2845 | In distribution | |
| 015.3545 | In distribution | |
| 015.3247 | In distribution | |
| 015.3242 | In distribution | |
| 015.5145 | In distribution | |
| 015.5530 | In distribution | |
| 015.5055 | In distribution | |
| 015.2852 | In distribution | |
| 015.0142 | In distribution | |
| 015.5045 | In distribution | |
| 015.3432 | In distribution | |
| 015.4330 | In distribution | |
| 015.3040 | In distribution | |
| 015.5092 | In distribution | |
| 015.6855 | In distribution | |
| 015.3477 | In distribution | |
| 015.6885 | In distribution | |
| 015.6950 | In distribution | |
| 015.4152 | In distribution | |
| 015.3032 | In distribution | |
| 015.5040 | In distribution | |
| 015.5057 | In distribution | |
| 015.6100 | In distribution | |
| 015.5150 | In distribution | |
| 015.3430 | In distribution | |
| 015.4155 | In distribution | |
| 015.3240 | In distribution | |
| 015.3450 | In distribution | |
| 015.3658 | In distribution | |
| 015.5047 | In distribution | |
| 015.3035 | In distribution | |
| 015.3257 | In distribution | |
| 015.4557 | In distribution | |
| 015.3492 | In distribution | |
| 015.4637 | In distribution | |
| 015.3472 | In distribution | |
| 015.4145 | In distribution | |
| 015.0160 | In distribution | |
| 015.3632 | In distribution | |
| 015.5342 | In distribution | |
| 015.6835 | In distribution | |
| 015.4335 | In distribution | |
| 015.5077 | In distribution | |
| 015.5042 | In distribution | |
| 015.5082 | In distribution | |
| 015.3683 | In distribution | |
| 015.5550 | D7.5 | In distribution |
| 015.4340 | In distribution | |
| 015.0148 | In distribution | |
| 015.3027 | In distribution | |
| 015.5072 | In distribution | |
| 015.4350 | In distribution | |
| 015.3435 | In distribution | |
| 015.2825 | In distribution | |
| 015.3042 | In distribution | |
| 015.4657 | In distribution | |
| 015.3057 | In distribution |
Showing 250 of 262 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.