Raphael Pedicle Screw System
RAPHAEL Polyaxial 40mm Reduction Screw, Cortical, Cannulated, 5.0 x L60mm
13manufacturers in China registered for this device type
237catalogue numbers in this listing
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 | CTL Medical Corporation, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K132365 |
| Record published | 2016-09-18 |
| Record revised | 2026-04-22 (version 7) |
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 |
| Sizes | Length 25 to 65 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115.1630 | Length 30 mm | In distribution |
| 115.0345 | D5.0 | In distribution |
| 115.1665 | D6.5 | In distribution |
| 115.2465 | Length 65 mm | In distribution |
| 115.5360 | D5.0 | In distribution |
| 115.0660 | Length 60 mm | In distribution |
| 115.3430 | Length 30 mm | In distribution |
| 115.0235 | Length 35 mm | In distribution |
| 115.5345 | D5.0 | In distribution |
| 115.4425 | Length 25 mm | In distribution |
| 115.5240 | D4.5 | In distribution |
| 115.5655 | Length 55 mm | In distribution |
| 115.2345 | Length 45 mm | In distribution |
| 115.4665 | D6.5 | In distribution |
| 115.2230 | D4.5 | In distribution |
| 115.3445 | Length 45 mm | In distribution |
| 015.7068 | In distribution | |
| 115.3665 | Length 65 mm | In distribution |
| 115.2445 | D5.5 | In distribution |
| 115.4465 | D5.5 | In distribution |
| 115.0450 | D5.5 | In distribution |
| 115.3325 | Length 25 mm | In distribution |
| 115.0335 | D5.0 | In distribution |
| 115.4650 | Length 50 mm | In distribution |
| 115.4255 | D4.5 | In distribution |
| 015.4357 | In distribution | |
| 115.3450 | Length 50 mm | In distribution |
| 115.5430 | D5.5 | In distribution |
| 115.2355 | D5.0 | In distribution |
| 015.4332 | In distribution | |
| 015.8105 | In distribution | |
| 115.1465 | D5.5 | In distribution |
| 115.1250 | Length 50 mm | In distribution |
| 015.4162 | In distribution | |
| 115.4355 | Length 55 mm | In distribution |
| 115.1625 | Length 25 mm | In distribution |
| 115.4445 | D5.5 | In distribution |
| 115.5245 | D4.5 | In distribution |
| 115.2640 | Length 40 mm | In distribution |
| 115.0460 | Length 60 mm | In distribution |
| 115.5225 | D4.5 | In distribution |
| 115.1355 | D5.0 | In distribution |
| 115.1335 | Length 35 mm | In distribution |
| 115.0330 | D5.0 | In distribution |
| 015.4337 | In distribution | |
| 115.2665 | D6.5 | In distribution |
| 115.0350 | Length 50 mm | In distribution |
| 115.0440 | Length 40 mm | In distribution |
| 115.5635 | D6.5 | In distribution |
| 115.2255 | Length 55 mm | In distribution |
| 115.1330 | D5.0 | In distribution |
| 115.0240 | D4.5 | In distribution |
| 115.1345 | Length 45 mm | In distribution |
| 115.2630 | D6.5 | In distribution |
| 115.2225 | D4.5 | In distribution |
| 115.5255 | Length 55 mm | In distribution |
| 015.4167 | In distribution | |
| 115.4350 | D5.0 | In distribution |
| 115.4460 | D5.5 | In distribution |
| 015.4347 | In distribution | |
| 115.2645 | Length 45 mm | In distribution |
| 115.5425 | D5.5 | In distribution |
| 115.5665 | Length 65 mm | In distribution |
| 015.8302 | In distribution | |
| 115.3645 | D6.5 | In distribution |
| 115.3335 | D5.0 | In distribution |
| 115.0455 | D5.5 | In distribution |
| 115.4660 | D6.5 | In distribution |
| 115.2340 | Length 40 mm | In distribution |
| 115.3330 | D5.0 | In distribution |
| 115.3440 | Length 40 mm | In distribution |
| 115.1660 | Length 60 mm | In distribution |
| 115.4440 | Length 40 mm | In distribution |
| 115.2425 | D5.5 | In distribution |
| 115.5445 | D5.5 | In distribution |
| 115.4260 | D4.5 | In distribution |
| 115.2440 | D5.5 | In distribution |
| 115.4430 | Length 30 mm | In distribution |
| 115.3635 | D6.5 | In distribution |
| 115.0430 | D5.5 | In distribution |
| 115.4340 | Length 40 mm | In distribution |
| 115.5340 | Length 40 mm | In distribution |
| 115.0645 | Length 45 mm | In distribution |
| 115.2450 | D5.5 | In distribution |
| 115.0340 | Length 40 mm | In distribution |
| 115.5440 | Length 40 mm | In distribution |
| 115.3260 | Length 60 mm | In distribution |
| 115.3640 | Length 40 mm | In distribution |
| 115.0355 | D5.0 | In distribution |
| 115.5645 | D6.5 | In distribution |
| 115.1240 | Length 40 mm | In distribution |
| 115.0635 | D6.5 | In distribution |
| 115.2335 | Length 35 mm | In distribution |
| 115.2635 | Length 35 mm | In distribution |
| 115.5355 | D5.0 | In distribution |
| 015.7066 | In distribution | |
| 115.0250 | D4.5 | In distribution |
| 015.8700 | In distribution | |
| 115.0435 | D5.5 | In distribution |
| 115.0325 | D5.0 | In distribution |
| 115.5325 | D5.0 | In distribution |
| 115.4230 | D4.5 | In distribution |
| 115.2435 | Length 35 mm | In distribution |
| 115.4450 | Length 50 mm | In distribution |
| 115.4360 | Length 60 mm | In distribution |
| 015.8121 | In distribution | |
| 115.1455 | Length 55 mm | In distribution |
| 115.5465 | Length 65 mm | In distribution |
| 115.4645 | D6.5 | In distribution |
| 115.5460 | D5.5 | In distribution |
| 115.2245 | D4.5 | In distribution |
| 115.2250 | D4.5 | In distribution |
| 115.4325 | Length 25 mm | In distribution |
| 115.1325 | D5.0 | In distribution |
| 115.3245 | D4.5 | In distribution |
| 115.2240 | D4.5 | In distribution |
| 115.1425 | Length 25 mm | In distribution |
| 115.1340 | Length 40 mm | In distribution |
| 115.1350 | D5.0 | In distribution |
| 115.3240 | Length 40 mm | In distribution |
| 115.3355 | D5.0 | In distribution |
| 115.2455 | Length 55 mm | In distribution |
| 115.4330 | D5.0 | In distribution |
| 115.4335 | D5.0 | In distribution |
| 115.5330 | Length 30 mm | In distribution |
| 115.2330 | D5.0 | In distribution |
| 015.8104 | In distribution | |
| 115.3655 | D6.5 | In distribution |
| 115.2325 | D5.0 | In distribution |
| 115.0640 | Length 40 mm | In distribution |
| 115.3630 | D6.5 | In distribution |
| 115.0360 | D5.0 | In distribution |
| 115.5455 | Length 55 mm | In distribution |
| 115.1435 | D5.5 | In distribution |
| 115.5450 | D5.5 | In distribution |
| 115.2360 | Length 60 mm | In distribution |
| 115.5230 | Length 30 mm | In distribution |
| 115.1440 | D5.5 | In distribution |
| 115.1450 | D5.5 | In distribution |
| 015.8100 | In distribution | |
| 115.0655 | D6.5 | In distribution |
| 115.1635 | D6.5 | In distribution |
| 115.1430 | D5.5 | In distribution |
| 115.5660 | Length 60 mm | In distribution |
| 115.5630 | D6.5 | In distribution |
| 115.3460 | Length 60 mm | In distribution |
| 115.3660 | D6.5 | In distribution |
| 115.4655 | Length 55 mm | In distribution |
| 115.0260 | D4.5 | In distribution |
| 115.0245 | Length 45 mm | In distribution |
| 015.8101 | In distribution | |
| 115.4345 | D5.0 | In distribution |
| 115.1655 | D6.5 | In distribution |
| 115.4435 | D5.5 | In distribution |
| 015.4352 | In distribution | |
| 115.5625 | D6.5 | In distribution |
| 115.3425 | Length 25 mm | In distribution |
| 115.2260 | Length 60 mm | In distribution |
| 115.2660 | D6.5 | In distribution |
| 115.1260 | D4.5 | In distribution |
| 115.1255 | Length 55 mm | In distribution |
| 115.3230 | Length 30 mm | In distribution |
| 115.5235 | D4.5 | In distribution |
| 115.4635 | D6.5 | In distribution |
| 115.0255 | Length 55 mm | In distribution |
| 115.3650 | Length 50 mm | In distribution |
| 015.7007 | In distribution | |
| 015.8106 | In distribution | |
| 115.3235 | Length 35 mm | In distribution |
| 115.5250 | D4.5 | In distribution |
| 015.4342 | In distribution | |
| 015.7008 | In distribution | |
| 115.1445 | D5.5 | In distribution |
| 115.1225 | Length 25 mm | In distribution |
| 115.0465 | D5.5 | In distribution |
| 115.1640 | D6.5 | In distribution |
| 115.4225 | Length 25 mm | In distribution |
| 115.2235 | D4.5 | In distribution |
| 115.0425 | Length 25 mm | In distribution |
| 015.6300 | In distribution | |
| 115.2650 | Length 50 mm | In distribution |
| 115.5640 | Length 40 mm | In distribution |
| 115.0665 | Length 65 mm | In distribution |
| 015.8200 | In distribution | |
| 115.4240 | D4.5 | In distribution |
| 115.1245 | D4.5 | In distribution |
| 115.4250 | Length 50 mm | In distribution |
| 115.3455 | D5.5 | In distribution |
| 115.2350 | D5.0 | In distribution |
| 115.1650 | Length 50 mm | In distribution |
| 115.2430 | Length 30 mm | In distribution |
| 115.3625 | D6.5 | In distribution |
| 015.4367 | In distribution | |
| 015.4372 | In distribution | |
| 015.8303 | In distribution | |
| 115.3360 | Length 60 mm | In distribution |
| 015.8701 | In distribution | |
| 115.0625 | D6.5 | In distribution |
| 015.4170 | In distribution | |
| 115.4455 | Length 55 mm | In distribution |
| 115.1460 | D5.5 | In distribution |
| 115.0630 | D6.5 | In distribution |
| 115.4245 | Length 45 mm | In distribution |
| 115.3350 | D5.0 | In distribution |
| 115.4625 | D6.5 | In distribution |
| 015.4362 | In distribution | |
| 115.3340 | Length 40 mm | In distribution |
| 115.5260 | Length 60 mm | In distribution |
| 115.5650 | D6.5 | In distribution |
| 015.8120 | In distribution | |
| 115.3435 | Length 35 mm | In distribution |
| 115.5435 | D5.5 | In distribution |
| 115.4640 | Length 40 mm | In distribution |
| 115.1235 | Length 35 mm | In distribution |
| 115.0225 | Length 25 mm | In distribution |
| 115.3255 | D4.5 | In distribution |
| 115.0445 | Length 45 mm | In distribution |
| 115.0650 | D6.5 | In distribution |
| 115.1360 | Length 60 mm | In distribution |
| 115.4235 | D4.5 | In distribution |
| 115.3250 | Length 50 mm | In distribution |
| 015.8110 | In distribution | |
| 115.2625 | Length 25 mm | In distribution |
| 115.1230 | Length 30 mm | In distribution |
| 015.8712 | In distribution | |
| 015.8711 | In distribution | |
| 115.1645 | D6.5 | In distribution |
| 115.2460 | D5.5 | In distribution |
| 115.5335 | D5.0 | In distribution |
| 115.0230 | Length 30 mm | In distribution |
| 115.5350 | D5.0 | In distribution |
| 115.3465 | D5.5 | In distribution |
| 115.3345 | D5.0 | In distribution |
| 115.2655 | Length 55 mm | In distribution |
| 115.3225 | Length 25 mm | In distribution |
| 015.6895 | In distribution | |
| 115.4630 | D6.5 | In distribution |
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 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal 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.