Prodigy Pedicle Screw System
Torque Limiting Axial Handle, 40 In-Lbs, 3/16" Square Connect
15manufacturers in China registered for this device type
364catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Curiteva, Inc., United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K191810 |
| Record published | 2023-12-29 |
| Record revised | 2025-12-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 1.4 to 8.5 mm; length 20 to 600 mm; width 0.146 to 0.18 mm; needle gauge 11 G; length 6 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C504-5545-DT | Outer Diameter 5.5 mm | In distribution |
| C504-6535-C | Outer Diameter 6.5 mm | In distribution |
| C505-510 | In distribution | |
| C514-7530 | Outer Diameter 7.5 mm | In distribution |
| C505-2400 | In distribution | |
| C505-800 | Outer Diameter 5.5 mm | In distribution |
| C504-R55-060C | Outer Diameter 5.5 mm | In distribution |
| C505-400-85 | Outer Diameter 8.5 mm | In distribution |
| C524-5550-DT | Outer Diameter 5.5 mm | In distribution |
| C504-R55-110C | Outer Diameter 5.5 mm | In distribution |
| C505-2110 | In distribution | |
| C514-7545 | Outer Diameter 7.5 mm | In distribution |
| C504-8560-DT | Outer Diameter 8.5 mm | In distribution |
| C504-R55-040 | Outer Diameter 5.5 mm | In distribution |
| C505-262 | Width.146 mm | In distribution |
| C504-6540-DT | Outer Diameter 6.5 mm | In distribution |
| C525-610 | In distribution | |
| C504-R55CC-500 | Outer Diameter 5.5 mm | In distribution |
| C504-6525 | Outer Diameter 6.5 mm | In distribution |
| C505-400-45 | Outer Diameter 4.5 mm | In distribution |
| C504-7545 | Outer Diameter 7.5 mm | In distribution |
| C524-5535 | Outer Diameter 5.5 mm | In distribution |
| C504-6565 | Outer Diameter 6.5 mm | In distribution |
| C505-1200 | In distribution | |
| C505-1801 | Outer Diameter 1.4 mm | In distribution |
| C514-7550 | Outer Diameter 7.5 mm | In distribution |
| C504-6550-DT | Outer Diameter 6.5 mm | In distribution |
| C504-7560-DT | Outer Diameter 7.5 mm | In distribution |
| C505-1101 | In distribution | |
| C504-6485-VCL | 64 – 85mm | In distribution |
| C524-7545-DT | Outer Diameter 7.5 mm | In distribution |
| C514-5545 | Outer Diameter 5.5 mm | In distribution |
| C525-1200 | In distribution | |
| C504-R55-045C | Outer Diameter 5.5 mm | In distribution |
| C504-8555-C | Outer Diameter 8.5 mm | In distribution |
| C505-2200 | In distribution | |
| C525-300 | In distribution | |
| C524-R55-120C | Outer Diameter 5.5 mm | In distribution |
| C504-8540C | Outer Diameter 8.5 mm | In distribution |
| C504-6535 | Outer Diameter 6.5 mm | In distribution |
| C524-5530-DT | Outer Diameter 5.5 mm | In distribution |
| C504-6555 | Outer Diameter 6.5 mm | In distribution |
| C504-7550-DT | Outer Diameter 7.5 mm | In distribution |
| C504-8555 | Outer Diameter 8.5 mm | In distribution |
| C515-100 | In distribution | |
| C504-8590 | Outer Diameter 8.5 mm | In distribution |
| C524-R55-055C | Outer Diameter 5.5 mm | In distribution |
| C554-5535-OF | Outer Diameter 5.5 mm | In distribution |
| C505-2180 | In distribution | |
| C504-7525 | Outer Diameter 7.5 mm | In distribution |
| C505-1500 | In distribution | |
| C514-6550 | Outer Diameter 6.5 mm | In distribution |
| C514-6545 | Outer Diameter 6.5 mm | In distribution |
| C504-5555-C | Outer Diameter 5.5 mm | In distribution |
| C505-420-55 | Outer Diameter 5.5 mm | In distribution |
| C524-6550 | Outer Diameter 6.5 mm | In distribution |
| C504-7555 | Outer Diameter 7.5 mm | In distribution |
| C524-R55-090C | Outer Diameter 5.5 mm | In distribution |
| C504-4550-DT | Outer Diameter 4.5 mm | In distribution |
| C504-8545C | Outer Diameter 8.5 mm | In distribution |
| C504-R55-065C | Outer Diameter 5.5 mm | In distribution |
| C554-5525-OF | Outer Diameter 5.5 mm | In distribution |
| C504-7540-C | Outer Diameter 7.5 mm | In distribution |
| C524-5555-DT | Outer Diameter 5.5 mm | In distribution |
| C504-6525-DT | Outer Diameter 6.5 mm | In distribution |
| C524-R55-100C | Outer Diameter 5.5 mm | In distribution |
| C554-5520-O | Outer Diameter 5.5 mm | In distribution |
| C504-R55-040C | Outer Diameter 5.5 mm | In distribution |
| C524-6525-DT | Outer Diameter 6.5 mm | In distribution |
| C504-4545-C | Outer Diameter 4.5 mm | In distribution |
| C524-6555 | Length 55 mm | In distribution |
| C505-200 | In distribution | |
| C525-110 | In distribution | |
| C524-5540-DT | Outer Diameter 5.5 mm | In distribution |
| C525-200 | In distribution | |
| C524-R55-150C | Outer Diameter 5.5 mm | In distribution |
| C504-4555-C | Outer Diameter 4.5 mm | In distribution |
| C504-5525 | Outer Diameter 5.5 mm | In distribution |
| C514-7555 | Outer Diameter 7.5 mm | In distribution |
| C505-1230 | In distribution | |
| C504-4535-DT | Outer Diameter 4.5 mm | In distribution |
| C505-1810-N | Outer Diameter 1.4 mm | In distribution |
| C504-R55-050C | Outer Diameter 5.5 mm | In distribution |
| C524-R55-075C | Outer Diameter 5.5 mm | In distribution |
| C514-6535 | Outer Diameter 6.5 mm | In distribution |
| C524-6560 | Outer Diameter 6.5 mm | In distribution |
| C504-85100 | Outer Diameter 8.5 mm | In distribution |
| C504-R55-400 | Outer Diameter 5.5 mm | In distribution |
| C504-4545-DT | Outer Diameter 4.5 mm | In distribution |
| C505-1110 | In distribution | |
| C504-R55-080 | Outer Diameter 5.5 mm | In distribution |
| C554-5530-OF | Outer Diameter 5.5 mm | In distribution |
| C505-1220 | In distribution | |
| C505-1400 | In distribution | |
| C525-710 | In distribution | |
| C554-C55-OAX | In distribution | |
| C554-5540-C | Outer Diameter 5.5 mm | In distribution |
| C504-5530-DT | Outer Diameter 5.5 mm | In distribution |
| C504-7530-DT | Outer Diameter 7.5 mm | In distribution |
| C505-400-65 | Outer Diameter 6.5 mm | In distribution |
| C524-7545 | Outer Diameter 7.5 mm | In distribution |
| C504-R55-500 | Outer Diameter 5.5 mm | In distribution |
| C505-501 | In distribution | |
| C524-6530-DT | Outer Diameter 6.5 mm | In distribution |
| C505-410-65 | Outer Diameter 6.5 mm | In distribution |
| C505-1911 | In distribution | |
| C505-2120 | In distribution | |
| C524-7540-DT | Outer Diameter 7.5 mm | In distribution |
| C505-2100 | In distribution | |
| C505-420-45 | Outer Diameter 4.5 mm | In distribution |
| C505-900 | In distribution | |
| C524-R55-070C | Outer Diameter 5.5 mm | In distribution |
| C524-5545 | Outer Diameter 5.5 mm | In distribution |
| C504-4525 | Outer Diameter 4.5 mm | In distribution |
| C505-100 | In distribution | |
| C505-710 | In distribution | |
| C554-C55-CCP | In distribution | |
| C525-100 | In distribution | |
| C514-7525 | Outer Diameter 7.5 mm | In distribution |
| C524-5560 | Outer Diameter 5.5 mm | In distribution |
| C505-272 | Width.146 mm | In distribution |
| C554-5520-CF | Outer Diameter 5.5 mm | In distribution |
| C524-6540-DT | Outer Diameter 6.5 mm | In distribution |
| C505-2160 | In distribution | |
| C504-7570 | Outer Diameter 7.5 mm | In distribution |
| C505-420-65 | Outer Diameter 6.5 mm | In distribution |
| C524-7535 | Outer Diameter 7.5 mm | In distribution |
| C554-5530-CF | Outer Diameter 5.5 mm | In distribution |
| C505-1900 | In distribution | |
| C504-7545-DT | Outer Diameter 7.5 mm | In distribution |
| C504-7555-C | Outer Diameter 7.5 mm | In distribution |
| C524-5545-DT | Outer Diameter 5.5 mm | In distribution |
| C504-R55-030 | Outer Diameter 5.5 mm | In distribution |
| C504-R55-100C | Outer Diameter 5.5 mm | In distribution |
| C525-910 | In distribution | |
| C504-R55-070 | Outer Diameter 5.5 mm | In distribution |
| C504-5550-DT | Outer Diameter 5.5 mm | In distribution |
| C504-5545-C | Outer Diameter 5.5 mm | In distribution |
| C524-7560 | Outer Diameter 7.5 mm | In distribution |
| C504-4465-VCL | 44 – 65mm | In distribution |
| C504-6545-C | Outer Diameter 6.5 mm | In distribution |
| C505-400-55 | Outer Diameter 5.5 mm | In distribution |
| C504-7565 | Outer Diameter 7.5 mm | In distribution |
| C504-8535 | Outer Diameter 8.5 mm | In distribution |
| C504-8545 | Outer Diameter 8.5 mm | In distribution |
| C504-7540-DT | Outer Diameter 7.5 mm | In distribution |
| C504-5535-C | Outer Diameter 5.5 mm | In distribution |
| C524-R55-160C | Outer Diameter 5.5 mm | In distribution |
| C504-R55-050 | Outer Diameter 5.5 mm | In distribution |
| C505-600 | In distribution | |
| C525-600 | In distribution | |
| C504-8525 | Outer Diameter 8.5 mm | In distribution |
| C554-C55-OOP | In distribution | |
| C504-5535 | Outer Diameter 5.5 mm | In distribution |
| C524-R55-400 | Outer Diameter 5.5 mm | In distribution |
| C504-6570 | Outer Diameter 6.5 mm | In distribution |
| C504-7550 | Outer Diameter 7.5 mm | In distribution |
| C504-7535 | Outer Diameter 7.5 mm | In distribution |
| C504-R55-030C | Outer Diameter 5.5 mm | In distribution |
| C505-300 | In distribution | |
| C504-R55-060 | Outer Diameter 5.5 mm | In distribution |
| C524-R55-170C | Outer Diameter 5.5 mm | In distribution |
| C554-C55-CAXL | In distribution | |
| C505-1800-N | Outer Diameter 1.4 mm | In distribution |
| C524-R55-110C | Outer Diameter 5.5 mm | In distribution |
| C504-5555 | Outer Diameter 5.5 mm | In distribution |
| C504-5540-DT | Outer Diameter 5.5 mm | In distribution |
| C514-6525 | Outer Diameter 6.5 mm | In distribution |
| C554-C55-OCP | In distribution | |
| C504-6530-DT | Outer Diameter 6.5 mm | In distribution |
| C514-5535 | Outer Diameter 5.5 mm | In distribution |
| C505-1411 | In distribution | |
| C505-292 | Width.180 mm | In distribution |
| C504-8540-DT | Outer Diameter 8.5 mm | In distribution |
| C504-R55-055C | Outer Diameter 5.5 mm | In distribution |
| C505-2000 | Outer Diameter 1.4 mm | In distribution |
| C504-8525-DT | Outer Diameter 8.5 mm | In distribution |
| C504-6555-C | Outer Diameter 6.5 mm | In distribution |
| C504-4560-DT | Outer Diameter 4.5 mm | In distribution |
| C514-6555 | Outer Diameter 6.5 mm | In distribution |
| C505-271 | Width.146 mm | In distribution |
| C505-310 | In distribution | |
| C525-1300 | In distribution | |
| C524-R55-050C | Outer Diameter 5.5 mm | In distribution |
| C554-5520-C | Outer Diameter 5.5 mm | In distribution |
| C504-5530-C | Outer Diameter 5.5 mm | In distribution |
| C504-8545-DT | Outer Diameter 8.5 mm | In distribution |
| C504-5560 | Outer Diameter 5.5 mm | In distribution |
| C504-75110 | Outer Diameter 7.5 mm | In distribution |
| C514-5530 | Outer Diameter 5.5 mm | In distribution |
| C554-5520-OF | Outer Diameter 5.5 mm | In distribution |
| C504-4530-DT | Outer Diameter 4.5 mm | In distribution |
| C554-C55-TTP | In distribution | |
| C504-4525-C | Outer Diameter 4.5 mm | In distribution |
| C504-8550-DT | Outer Diameter 8.5 mm | In distribution |
| C525-120 | In distribution | |
| C505-400-75 | Outer Diameter 7.5 mm | In distribution |
| C504-R55-100 | Outer Diameter 5.5 mm | In distribution |
| C505-2700 | In distribution | |
| C524-R55-175C | Outer Diameter 5.5 mm | In distribution |
| C525-900 | In distribution | |
| C524-6545-DT | Outer Diameter 6.5 mm | In distribution |
| C504-8550-C | Outer Diameter 8.5 mm | In distribution |
| C504-4555 | Outer Diameter 4.5 mm | In distribution |
| C514-6540 | Outer Diameter 6.5 mm | In distribution |
| C504-6530 | Outer Diameter 6.5 mm | In distribution |
| C504-7535-DT | Outer Diameter 7.5 mm | In distribution |
| C525-700 | In distribution | |
| C504-7555-DT | Outer Diameter 7.5 mm | In distribution |
| C504-6530-C | Outer Diameter 6.5 mm | In distribution |
| C524-6530 | Outer Diameter 6.5 mm | In distribution |
| C504-7525-DT | Outer Diameter 7.5 mm | In distribution |
| C505-1000 | In distribution | |
| C504-4545 | Outer Diameter 4.5 mm | In distribution |
| C524-R55-165C | Outer Diameter 5.5 mm | In distribution |
| C504-8560 | Outer Diameter 8.5 mm | In distribution |
| C504-R55-150C | Outer Diameter 5.5 mm | In distribution |
| C505-503 | In distribution | |
| C524-7550 | Outer Diameter 7.5 mm | In distribution |
| C524-5555 | Outer Diameter 5.5 mm | In distribution |
| C525-800 | Needle Gauge 11 G | In distribution |
| C504-R55-130C | Outer Diameter 5.5 mm | In distribution |
| C524-5540 | Outer Diameter 5.5 mm | In distribution |
| C504-8540 | Outer Diameter 8.5 mm | In distribution |
| C505-410-55 | Outer Diameter 5.5 mm | In distribution |
| C505-502 | In distribution | |
| C505-720 | In distribution | |
| C504-6535-DT | Outer Diameter 6.5 mm | In distribution |
| C504-6550-C | Outer Diameter 6.5 mm | In distribution |
| C504-7590 | Outer Diameter 7.5 mm | In distribution |
| C504-7530 | Outer Diameter 7.5 mm | In distribution |
| C504-4535-C | Outer Diameter 4.5 mm | In distribution |
| C504-R55-070C | Outer Diameter 5.5 mm | In distribution |
| C505-1800 | Outer Diameter 1.4 mm | In distribution |
| C504-4530-C | Outer Diameter 4.5 mm | In distribution |
| C504-7540 | Outer Diameter 7.5 mm | In distribution |
| C524-R55-035C | Outer Diameter 5.5 mm | In distribution |
| C504-8555-DT | Outer Diameter 8.5 mm | In distribution |
| C504-6540 | Outer Diameter 6.5 mm | In distribution |
| C524-7530-DT | Outer Diameter 7.5 mm | In distribution |
| C504-4550-C | Outer Diameter 4.5 mm | In distribution |
| C504-5545 | Outer Diameter 5.5 mm | In distribution |
| C504-R55CC-PB | Outer Diameter 5.5 mm | In distribution |
| C504-R55-160C | Outer Diameter 5.5 mm | In distribution |
| C504-5525-DT | Outer Diameter 5.5 mm | In distribution |
| C525-1100 | In distribution | |
| C524-R55-300 | Outer Diameter 5.5 mm | In distribution |
| C505-2300 | In distribution | |
| C554-C55-TAP | In distribution | |
| C504-7530-C | Outer Diameter 7.5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191810 | 2019-08-28 |
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.