Xpine Spinal Fixation System
Xpine is a spinal fixation system combining pedicle screws, rods, set screws and crosslinks. The construct immobilizes and stabilizes thoracic, lumbar or sacral spinal segments as an…
Xpine is a spinal fixation system combining pedicle screws, rods, set screws and crosslinks. The construct immobilizes and stabilizes thoracic, lumbar or sacral spinal segments as an adjunct to fusion.
The implants are titanium alloy and come in different forms and sizes. Screws provide bone anchors, rods connect those anchors, and set screws lock the rod connections within the assembly.
Construct Scope
Crosslinks connect the rods across the construct where used. The system is intended for non-cervical pedicle fixation in skeletally mature adults and is supplied nonsterile; pediatric or anterolateral uses of other systems are outside this configuration.
15manufacturers in China registered for this device type
753catalogue 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 | Jeil Medical Corporation, South Korea |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K243004 |
| Record published | 2024-11-12 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L69-M60A-4020 | In distribution | |
| L69-RM60A-8580 | In distribution | |
| L69-M60A-7540 | In distribution | |
| L69-P60A-6055 | In distribution | |
| L69-TSR-55240 | In distribution | |
| L69-RM60A-8035 | In distribution | |
| L69-RM60A-8085 | In distribution | |
| L69-P60A-95100 | In distribution | |
| L69-RP60A-7040 | In distribution | |
| L69-RM60A-6585 | In distribution | |
| L69-P60A-8595 | In distribution | |
| L69-RM60A-7045 | In distribution | |
| L69-RM60A-5025 | In distribution | |
| L69-TCR-6030 | In distribution | |
| L69-TSR-60200 | In distribution | |
| L69-TSR-55290 | In distribution | |
| L69-M60A-6555 | In distribution | |
| L69-P60A-8530 | In distribution | |
| L69-RM60A-7065 | In distribution | |
| L69-M60A-8540 | In distribution | |
| L69-RP60A-6590 | In distribution | |
| L69-RM60A-7040 | In distribution | |
| L69-RP60A-6035 | In distribution | |
| L69-TCR-6090 | In distribution | |
| L69-RP60A-7590 | In distribution | |
| L69-TSR-60145 | In distribution | |
| L69-M60A-6535 | In distribution | |
| L69-CLA-3034 | In distribution | |
| L69-RM60A-6040 | In distribution | |
| L69-P60A-7060 | In distribution | |
| L69-M60A-4060 | In distribution | |
| L69-RM60A-6530 | In distribution | |
| L69-TSR-60125 | In distribution | |
| L69-RP60A-6040 | In distribution | |
| L69-RM60A-5040 | In distribution | |
| L69-TSR-60380 | In distribution | |
| L69-P60A-7575 | In distribution | |
| L69-P60A-6570 | In distribution | |
| L69-M60A-7080 | In distribution | |
| L69-P60A-8565 | In distribution | |
| L69-RP60A-5535 | In distribution | |
| L69-RP60A-4550 | In distribution | |
| L69-P60A-9530 | In distribution | |
| L69-M60A-5035 | In distribution | |
| L69-RP60A-9070 | In distribution | |
| L69-RM60A-7580 | In distribution | |
| L69-RP60A-9065 | In distribution | |
| L69-TSR-6070 | In distribution | |
| L69-P60A-8090 | In distribution | |
| L69-RM60A-5545 | In distribution | |
| L69-TCR-6065 | In distribution | |
| L69-RP60A-8050 | In distribution | |
| L69-RP60A-5555 | In distribution | |
| L69-RP60A-65100 | In distribution | |
| L69-P60A-8560 | In distribution | |
| L69-TSR-60120 | In distribution | |
| L69-RM60A-85100 | In distribution | |
| L69-M60A-6060 | In distribution | |
| L69-P60A-9580 | In distribution | |
| L69-M60A-6045 | In distribution | |
| L69-RP60A-70100 | In distribution | |
| L69-TSR-55400 | In distribution | |
| L69-P60A-7070 | In distribution | |
| L69-P60A-7065 | In distribution | |
| L69-P60A-9540 | In distribution | |
| L69-P60A-8520 | In distribution | |
| L69-RM60A-8575 | In distribution | |
| L69-P60A-9080 | In distribution | |
| L69-P60S-9505 | In distribution | |
| L69-TCR-5595 | In distribution | |
| L69-TSR-60140 | In distribution | |
| L69-RP60A-6580 | In distribution | |
| L69-P60A-5535 | In distribution | |
| L69-TSR-60150 | In distribution | |
| L69-RM60A-7570 | In distribution | |
| L69-TSR-55165 | In distribution | |
| L69-TCR-55135 | In distribution | |
| L69-TSR-55150 | In distribution | |
| L69-TSR-5545 | In distribution | |
| L69-M60A-4560 | In distribution | |
| L69-M60A-5055 | In distribution | |
| L69-RP60A-4555 | In distribution | |
| L69-M60A-5060 | In distribution | |
| L69-M60A-8525 | In distribution | |
| L69-RP60A-8020 | In distribution | |
| L69-RP60A-6570 | In distribution | |
| L69-RM60A-7525 | In distribution | |
| L69-RP60A-5055 | In distribution | |
| L69-M60A-4025 | In distribution | |
| L69-P60A-9555 | In distribution | |
| L69-P60A-4530 | In distribution | |
| L69-TSR-55330 | In distribution | |
| L69-RM60A-8090 | In distribution | |
| L69-M60A-7565 | In distribution | |
| L69-RM60A-8595 | In distribution | |
| L69-RM60A-7070 | In distribution | |
| L69-RP60A-8055 | In distribution | |
| L69-M60A-5040 | In distribution | |
| L69-RP60A-6055 | In distribution | |
| L69-RP60A-7020 | In distribution | |
| L69-M60A-6530 | In distribution | |
| L69-RP60A-7075 | In distribution | |
| L69-TCR-5530 | In distribution | |
| L69-P60A-5530 | In distribution | |
| L69-RP60A-5540 | In distribution | |
| L69-TCR-6070 | In distribution | |
| L69-TSR-6055 | In distribution | |
| L69-RP60A-8585 | In distribution | |
| L69-RP60A-9585 | In distribution | |
| L69-TCR-6095 | In distribution | |
| L69-RM60A-8095 | In distribution | |
| L69-RM60A-6050 | In distribution | |
| L69-TCR-5545 | In distribution | |
| L69-TSR-60310 | In distribution | |
| L69-M60A-6560 | In distribution | |
| L69-M60A-8055 | In distribution | |
| L69-RP60A-7560 | In distribution | |
| L69-M60A-7050 | In distribution | |
| L69-M60A-8535 | In distribution | |
| L69-RM60A-6595 | In distribution | |
| L69-P60A-9060 | In distribution | |
| L69-TSR-60115 | In distribution | |
| L69-RP60A-4540 | In distribution | |
| L69-TCR-60110 | In distribution | |
| L69-RM60A-8040 | In distribution | |
| L69-RM60A-8520 | In distribution | |
| L69-P60A-5035 | In distribution | |
| L69-TSR-55160 | In distribution | |
| L69-M60A-5530 | In distribution | |
| L69-TSR-6065 | In distribution | |
| L69-P60A-5545 | In distribution | |
| L69-RM60A-8080 | In distribution | |
| L69-P60A-5550 | In distribution | |
| L69-P60A-9535 | In distribution | |
| L69-RM60A-70100 | In distribution | |
| L69-RP60A-9530 | In distribution | |
| L69-RP60A-8090 | In distribution | |
| L69-RP60A-8040 | In distribution | |
| L69-TCR-55130 | In distribution | |
| L69-M60A-6585 | In distribution | |
| L69-TSR-5555 | In distribution | |
| L69-M60A-7065 | In distribution | |
| L69-TSR-60110 | In distribution | |
| L69-P60A-9085 | In distribution | |
| L69-RP60A-4560 | In distribution | |
| L69-TSR-55145 | In distribution | |
| L69-P60A-7040 | In distribution | |
| L69-TSR-60170 | In distribution | |
| L69-RM60A-4020 | In distribution | |
| L69-P60A-6560 | In distribution | |
| L69-TSR-5575 | In distribution | |
| L69-RM60A-6570 | In distribution | |
| L69-M60A-4030 | In distribution | |
| L69-RM60A-8025 | In distribution | |
| L69-RP60A-6575 | In distribution | |
| L69-P60A-7565 | In distribution | |
| L69-RP60A-9085 | In distribution | |
| L69-M60A-8560 | In distribution | |
| L69-TSR-6085 | In distribution | |
| L69-TSR-6080 | In distribution | |
| L69-P60A-8545 | In distribution | |
| L69-M60A-4535 | In distribution | |
| L69-P60A-6525 | In distribution | |
| L69-P60A-8555 | In distribution | |
| L69-RP60A-5045 | In distribution | |
| L69-RP60A-4050 | In distribution | |
| L69-M60A-8050 | In distribution | |
| L69-TSR-60320 | In distribution | |
| L69-P60A-6590 | In distribution | |
| L69-P60A-9545 | In distribution | |
| L69-RP60A-9020 | In distribution | |
| L69-M60A-4530 | In distribution | |
| L69-P60A-6575 | In distribution | |
| L69-P60A-9590 | In distribution | |
| L69-M60A-5540 | In distribution | |
| L69-M60A-6025 | In distribution | |
| L69-RM60A-5035 | In distribution | |
| L69-P60A-4040 | In distribution | |
| L69-M60A-7040 | In distribution | |
| L69-RM60A-7550 | In distribution | |
| L69-RM60A-5045 | In distribution | |
| L69-RP60A-9525 | In distribution | |
| L69-M60A-6545 | In distribution | |
| L69-M60A-7095 | In distribution | |
| L69-RP60A-8580 | In distribution | |
| L69-TSR-55105 | In distribution | |
| L69-TSR-60340 | In distribution | |
| L69-RP60A-9570 | In distribution | |
| L69-RP60A-6525 | In distribution | |
| L69-TSR-55155 | In distribution | |
| L69-M60A-5045 | In distribution | |
| L69-P60A-6020 | In distribution | |
| L69-M60A-6550 | In distribution | |
| L69-TSR-55280 | In distribution | |
| L69-RP60A-7555 | In distribution | |
| L69-P60A-7570 | In distribution | |
| L69-TSR-55250 | In distribution | |
| L69-P60A-4560 | In distribution | |
| L69-TSR-55110 | In distribution | |
| L69-RP60A-6565 | In distribution | |
| L69-RM60A-4555 | In distribution | |
| L69-RP60A-6560 | In distribution | |
| L69-M60A-8545 | In distribution | |
| L69-M60A-4035 | In distribution | |
| L69-P60A-8095 | In distribution | |
| L69-RM60A-7085 | In distribution | |
| L69-RP60A-5560 | In distribution | |
| L69-RP60A-8570 | In distribution | |
| L69-P60A-4035 | In distribution | |
| L69-M60A-8555 | In distribution | |
| L69-RP60A-9075 | In distribution | |
| L69-M60A-6570 | In distribution | |
| L69-TSR-60155 | In distribution | |
| L69-M60A-7060 | In distribution | |
| L69-TSR-60105 | In distribution | |
| L69-P60A-7555 | In distribution | |
| L69-P60A-9095 | In distribution | |
| L69-M60A-8065 | In distribution | |
| L69-TCR-55115 | In distribution | |
| L69-RM60A-6020 | In distribution | |
| L69-RP60A-8060 | In distribution | |
| L69-RM60A-8565 | In distribution | |
| L69-P60A-7050 | In distribution | |
| L69-RP60A-6520 | In distribution | |
| L69-RM60A-7025 | In distribution | |
| L69-RP60A-6545 | In distribution | |
| L69-RP60A-90100 | In distribution | |
| L69-TSR-60300 | In distribution | |
| L69-P60A-5025 | In distribution | |
| L69-RM60A-6540 | In distribution | |
| L69-RM60A-8540 | In distribution | |
| L69-RP60A-8095 | In distribution | |
| L69-TSR-60210 | In distribution | |
| L69-TSR-6060 | In distribution | |
| L69-RM60A-5050 | In distribution | |
| L69-P60A-8550 | In distribution | |
| L69-TCR-60130 | In distribution | |
| L69-TSR-6045 | In distribution | |
| L69-M60A-7595 | In distribution | |
| L69-TSR-55210 | In distribution | |
| L69-M60A-75100 | In distribution | |
| L69-M60A-4555 | In distribution | |
| L69-TCR-55110 | In distribution | |
| L69-RP60A-7035 | In distribution | |
| L69-M60A-8045 | In distribution | |
| L69-RP60A-9520 | In distribution | |
| L69-TCR-6060 | In distribution | |
| L69-RP60A-9580 | In distribution | |
| L69-M60A-8035 | In distribution | |
| L69-P60A-7095 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| 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 |
|---|---|
| K243004 | 2024-11-08 |
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.