Riva Pedicle Screw System
BONE SCREW, CORTICAL CANCELLOUS, 11.5mm X 110mm
15manufacturers in China registered for this device type
1,038catalogue numbers in this listing
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 | Xenix Medical, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K251154 |
| Record published | 2026-06-01 |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG1-15-200060 | In distribution | |
| FG1-32-125055 | In distribution | |
| FG1-32-075080 | In distribution | |
| FG1-32-105065 | In distribution | |
| FG1-15-102450 | In distribution | |
| FG1-16-140065 | In distribution | |
| FG1-32-045075 | In distribution | |
| FG1-32-095075 | In distribution | |
| FG1-16-231600 | In distribution | |
| FG1-15-031250 | In distribution | |
| FG1-15-210050 | In distribution | |
| FG1-16-040300 | In distribution | |
| FG1-30-115045 | In distribution | |
| FG1-32-115070 | In distribution | |
| FG1-16-202085 | In distribution | |
| FG1-32-125045 | In distribution | |
| FG1-15-202080 | In distribution | |
| FG1-16-000025 | In distribution | |
| FG1-16-0120030 | In distribution | |
| FG1-15-112100 | In distribution | |
| FG1-16-000090 | In distribution | |
| FG1-15-140550 | In distribution | |
| FG1-30-095075 | In distribution | |
| FG1-15-140055 | In distribution | |
| FG1-16-212030 | In distribution | |
| FG1-15-212120 | In distribution | |
| FG1-15-000500 | In distribution | |
| FG1-15-101400 | In distribution | |
| FG1-15-200085 | In distribution | |
| FG1-16-200450 | In distribution | |
| FG1-15-102085 | In distribution | |
| FG1-30-075055 | In distribution | |
| FG1-15-102140 | In distribution | |
| FG1-15-240600 | In distribution | |
| FG1-15-140090 | In distribution | |
| FG1-15-220100 | In distribution | |
| FG1-30-055060 | In distribution | |
| FG1-16-020150 | In distribution | |
| FG1-32-065110 | In distribution | |
| FG1-16-212130 | In distribution | |
| FG1-30-105050 | In distribution | |
| FG1-16-212120 | In distribution | |
| FG1-15-200095 | In distribution | |
| FG1-15-140110 | In distribution | |
| FG1-15-040500 | In distribution | |
| FG1-32-085100 | In distribution | |
| FG1-30-085060 | In distribution | |
| FG1-32-055085 | In distribution | |
| FG1-15-200300 | In distribution | |
| FG1-16-240060 | In distribution | |
| FG1-16-031400 | In distribution | |
| FG1-16-231450 | In distribution | |
| FG1-32-055110 | In distribution | |
| FG1-32-085075 | In distribution | |
| FG1-16-000600 | In distribution | |
| FG1-30-045040 | In distribution | |
| FG1-15-140080 | In distribution | |
| FG1-32-065100 | In distribution | |
| FG1-32-115110 | In distribution | |
| FG1-32-085095 | In distribution | |
| FG1-30-055105 | In distribution | |
| FG1-15-0120120 | In distribution | |
| FG1-32-085085 | In distribution | |
| FG1-30-125050 | In distribution | |
| FG1-16-020100 | In distribution | |
| FG1-32-115035 | In distribution | |
| FG1-16-140450 | In distribution | |
| FG1-32-115045 | In distribution | |
| FG1-32-045070 | In distribution | |
| FG1-15-200110 | In distribution | |
| FG1-16-040400 | In distribution | |
| FG1-16-210045 | In distribution | |
| FG1-16-101200 | In distribution | |
| FG1-15-112035 | In distribution | |
| FG1-30-065065 | In distribution | |
| FG1-16-112080 | In distribution | |
| FG1-16-210060 | In distribution | |
| FG1-16-231200 | In distribution | |
| FG1-32-095045 | In distribution | |
| FG1-15-102110 | In distribution | |
| FG1-16-102085 | In distribution | |
| FG1-15-140130 | In distribution | |
| FG1-16-102080 | In distribution | |
| FG1-15-140400 | In distribution | |
| FG1-16-220100 | In distribution | |
| FG1-010030 | In distribution | |
| FG1-30-115035 | In distribution | |
| FG1-16-000040 | In distribution | |
| FG1-15-000130 | In distribution | |
| FG1-32-065085 | In distribution | |
| FG1-16-140040 | In distribution | |
| FG1-30-095100 | In distribution | |
| FG1-30-085095 | In distribution | |
| FG1-16-212070 | In distribution | |
| FG1-15-000025 | In distribution | |
| FG1-16-112045 | In distribution | |
| FG1-15-200045 | In distribution | |
| FG1-30-095060 | In distribution | |
| FG1-16-200050 | In distribution | |
| FG1-15-210035 | In distribution | |
| FG1-30-105060 | In distribution | |
| FG1-15-212040 | In distribution | |
| FG1-16-102140 | In distribution | |
| FG1-16-131350 | In distribution | |
| FG1-16-102075 | In distribution | |
| FG1-16-020120 | In distribution | |
| FG1-30-105085 | In distribution | |
| FG1-30-095065 | In distribution | |
| FG1-16-200600 | In distribution | |
| FG1-16-102500 | In distribution | |
| FG1-16-240600 | In distribution | |
| FG1-16-040070 | In distribution | |
| FG1-30-085105 | In distribution | |
| FG1-16-102120 | In distribution | |
| FG1-16-131250 | In distribution | |
| FG1-16-231250 | In distribution | |
| FG1-15-102550 | In distribution | |
| FG1-30-045090 | In distribution | |
| FG1-15-210095 | In distribution | |
| FG1-16-212100 | In distribution | |
| FG1-16-000110 | In distribution | |
| FG1-15-210130 | In distribution | |
| FG1-16-140060 | In distribution | |
| FG1-32-125095 | In distribution | |
| FG1-16-0120035 | In distribution | |
| FG1-16-202050 | In distribution | |
| FG1-32-055090 | In distribution | |
| FG1-15-0120140 | In distribution | |
| FG1-15-240550 | In distribution | |
| FG1-16-140075 | In distribution | |
| FG1-30-065055 | In distribution | |
| FG1-30-045095 | In distribution | |
| FG1-30-095095 | In distribution | |
| FG1-16-0120140 | In distribution | |
| FG1-15-040200 | In distribution | |
| FG1-16-240140 | In distribution | |
| FG1-16-212110 | In distribution | |
| FG1-15-240075 | In distribution | |
| FG1-16-0120025 | In distribution | |
| FG1-30-075110 | In distribution | |
| FG1-16-120140 | In distribution | |
| FG1-15-112055 | In distribution | |
| FG1-15-102030 | In distribution | |
| FG1-15-240050 | In distribution | |
| FG1-16-201350 | In distribution | |
| FG1-15-040350 | In distribution | |
| FG1-32-055095 | In distribution | |
| FG1-15-200150 | In distribution | |
| FG1-15-212130 | In distribution | |
| FG1-15-0000110 | In distribution | |
| FG1-15-220120 | In distribution | |
| FG1-15-210100 | In distribution | |
| FG1-30-045070 | In distribution | |
| FG1-15-200025 | In distribution | |
| FG1-30-115050 | In distribution | |
| FG1-15-140250 | In distribution | |
| FG1-16-101300 | In distribution | |
| FG1-16-210035 | In distribution | |
| FG1-32-085025 | In distribution | |
| FG1-16-202350 | In distribution | |
| FG1-15-040085 | In distribution | |
| FG1-15-140045 | In distribution | |
| FG1-16-020190 | In distribution | |
| FG1-16-102110 | In distribution | |
| FG1-15-200450 | In distribution | |
| FG1-15-040080 | In distribution | |
| FG1-30-125055 | In distribution | |
| FG1-16-040095 | In distribution | |
| FG1-15-201550 | In distribution | |
| FG1-16-140110 | In distribution | |
| FG1-30-075095 | In distribution | |
| FG1-15-040090 | In distribution | |
| FG1-16-010065 | In distribution | |
| FG1-16-120190 | In distribution | |
| FG1-15-200100 | In distribution | |
| FG1-15-000300 | In distribution | |
| FG1-15-300030 | In distribution | |
| FG1-15-300025 | In distribution | |
| FG1-30-085070 | In distribution | |
| FG1-40-603952 | In distribution | |
| FG1-16-212095 | In distribution | |
| FG1-15-0120110 | In distribution | |
| FG1-32-095030 | In distribution | |
| FG1-15-000400 | In distribution | |
| FG1-15-231350 | In distribution | |
| FG1-16-040140 | In distribution | |
| FG1-30-065085 | In distribution | |
| FG1-16-112100 | In distribution | |
| FG1-16-240400 | In distribution | |
| FG1-30-115060 | In distribution | |
| FG1-32-115055 | In distribution | |
| FG1-16-102130 | In distribution | |
| FG1-16-131300 | In distribution | |
| FG1-16-000035 | In distribution | |
| FG1-30-055030 | In distribution | |
| FG1-16-020130 | In distribution | |
| FG1-30-055070 | In distribution | |
| FG1-15-040110 | In distribution | |
| FG1-32-115060 | In distribution | |
| FG1-15-200600 | In distribution | |
| FG1-16-0120065 | In distribution | |
| FG1-16-010095 | In distribution | |
| FG1-30-085040 | In distribution | |
| FG1-15-020120 | In distribution | |
| FG1-16-140120 | In distribution | |
| FG1-32-095060 | In distribution | |
| FG1-16-040500 | In distribution | |
| FG1-16-140085 | In distribution | |
| FG1-16-200200 | In distribution | |
| FG1-32-115040 | In distribution | |
| FG1-15-200400 | In distribution | |
| FG1-16-240045 | In distribution | |
| FG1-16-240080 | In distribution | |
| FG1-30-045045 | In distribution | |
| FG1-16-040200 | In distribution | |
| FG1-15-031350 | In distribution | |
| FG1-16-240450 | In distribution | |
| FG1-32-075025 | In distribution | |
| FG1-15-202350 | In distribution | |
| FG1-16-112090 | In distribution | |
| FG1-16-020140 | In distribution | |
| FG1-15-220190 | In distribution | |
| FG1-15-101300 | In distribution | |
| FG1-15-031450 | In distribution | |
| FG1-16-140350 | In distribution | |
| FG1-16-140250 | In distribution | |
| FG1-15-112060 | In distribution | |
| FG1-15-140100 | In distribution | |
| FG1-16-140600 | In distribution | |
| FG1-32-085065 | In distribution | |
| FG1-15-201600 | In distribution | |
| FG1-32-105100 | In distribution | |
| FG1-16-112070 | In distribution | |
| FG1-32-045085 | In distribution | |
| FG1-15-200080 | In distribution | |
| FG1-16-120120 | In distribution | |
| FG1-15-0120100 | In distribution | |
| FG1-30-055055 | In distribution | |
| FG1-32-105030 | In distribution | |
| FG1-16-120100 | In distribution | |
| FG1-15-200055 | In distribution | |
| FG1-32-095050 | In distribution | |
| FG1-15-212035 | In distribution | |
| FG1-16-210085 | In distribution | |
| FG1-30-105030 | In distribution | |
| FG1-15-101550 | In distribution | |
| FG1-16-140300 | In distribution | |
| FG1-16-031550 | In distribution | |
| FG1-16-200140 | In distribution | |
| FG1-32-125070 | In distribution |
Showing 250 of 300 catalogue numbers.
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|---|---|---|
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| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
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| 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
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.