#REF!
4.75 x 115 mm CoCr-Standard Curved Rod
15manufacturers in China registered for this device type
53catalogue numbers in this listing
1510(k) clearance
4recalls on this code
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 | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2025-11-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-587611CH | Device Size Text, specify—4.75 X 110 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587912CL | Device Size Text, specify—4.75 X 125 MM COCR-LOW CURVED ROD | In distribution |
| 14-587604CS | Device Size Text, specify—4.75 X 40 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587904CL | Device Size Text, specify—4.75 X 45 MM COCR-LOW CURVED ROD | In distribution |
| 14-587606CL | Device Size Text, specify—4.75 X 60 MM COCR-LOW CURVED ROD | In distribution |
| 14-587911CS | Device Size Text, specify—4.75 X 115 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587606CH | Device Size Text, specify—4.75 X 60 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587903CS | Device Size Text, specify—4.75 X 35 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587904CS | Device Size Text, specify—4.75 X 45 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587603CH | Device Size Text, specify—4.75 X 30 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587603CS | Device Size Text, specify—4.75 X 30 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587611CL | Device Size Text, specify—4.75 X 110 MM COCR-LOW CURVED ROD | In distribution |
| 14-587904T | Device Size Text, specify—4.75 x 45 mm Ti Alloy Curved Rod | In distribution |
| 14-587912CS | Device Size Text, specify—4.75 X 125 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587613T | Device Size Text, specify—4.75 x 130 mm Ti Alloy Curved Rod | In distribution |
| 14-587910CH | Device Size Text, specify—4.75 X 105 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587612CS | Device Size Text, specify—4.75 X 120 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587613CH | Device Size Text, specify—4.75 X 130 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587613CL | Device Size Text, specify—4.75 X 130 MM COCR-LOW CURVED ROD | In distribution |
| 14-587605CL | Device Size Text, specify—4.75 X 50 MM COCR-LOW CURVED ROD | In distribution |
| 14-587905CS | Device Size Text, specify—4.75 X 55 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587912T | Device Size Text, specify—4.75 x 125 mm Ti Alloy Curved Rod | In distribution |
| 14-587605T | Device Size Text, specify—4.75 x 50 mm Ti Alloy Curved Rod | In distribution |
| 14-587611CS | Device Size Text, specify—4.75 X 110 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587903CH | Device Size Text, specify—4.75 X 35 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587612CH | Device Size Text, specify—4.75 X 120 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587911T | Device Size Text, specify—4.75 x 115 mm Ti Alloy Curved Rod | In distribution |
| 14-587911CL | Device Size Text, specify—4.75 X 115 MM COCR-LOW CURVED ROD | In distribution |
| 14-587610T | Device Size Text, specify—4.75 x 100 mm Ti Alloy Curved Rod | In distribution |
| 14-587905CH | Device Size Text, specify—4.75 X 55 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587904CH | Device Size Text, specify—4.75 X 45 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587612CL | Device Size Text, specify—4.75 X 120 MM COCR-LOW CURVED ROD | In distribution |
| 14-587605CH | Device Size Text, specify—4.75 X 50 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587603CL | Device Size Text, specify—4.75 X 30 MM COCR-LOW CURVED ROD | In distribution |
| 14-587911CH | Device Size Text, specify—4.75 X 115 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587603T | Device Size Text, specify—4.75 x 30 mm Ti Alloy Curved Rod | In distribution |
| 14-587611T | Device Size Text, specify—4.75 x 110 mm Ti Alloy Curved Rod | In distribution |
| 14-587604CH | Device Size Text, specify—4.75 X 40 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587912CH | Device Size Text, specify—4.75 X 125 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587910CS | Device Size Text, specify—4.75 X 105 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587905T | Device Size Text, specify—4.75 x 55 mm Ti Alloy Curved Rod | In distribution |
| 14-587610CL | Device Size Text, specify—4.75 X 100 MM COCR-LOW CURVED ROD | In distribution |
| 14-587605CS | Device Size Text, specify—4.75 X 50 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587604CL | Device Size Text, specify—4.75 X 40 MM COCR-LOW CURVED ROD | In distribution |
| 14-587910T | Device Size Text, specify—4.75 x 105 mm Ti Alloy Curved Rod | In distribution |
| 14-587903CL | Device Size Text, specify—4.75 X 35 MM COCR-LOW CURVED ROD | In distribution |
| 14-587610CH | Device Size Text, specify—4.75 X 100 MM COCR-HIGH CURVED ROD | In distribution |
| 14-587612T | Device Size Text, specify—4.75 x 120 mm Ti Alloy Curved Rod | In distribution |
| 14-587610CS | Device Size Text, specify—4.75 X 100 MM COCR-STANDARD CURVED ROD | In distribution |
| 14-587903T | Device Size Text, specify—4.75 x 35 mm Ti Alloy Curved Rod | In distribution |
| 14-587604T | Device Size Text, specify—4.75 x 40 mm Ti Alloy Curved Rod | In distribution |
| 14-587905CL | Device Size Text, specify—4.75 X 55 MM COCR-LOW CURVED ROD | In distribution |
| 14-587613CS | Device Size Text, specify—4.75 X 130 MM COCR-STANDARD CURVED ROD | In distribution |
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 |
|---|---|
| K253093 | 2025-12-17 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-10-16 | Class II | Nonconforming Material/Component | Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indent | 3 | |
| 2018-07-30 | Class II | Nonconforming Material/Component | The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications | 16,429 devices (Thoracolumbosacral pedicle screw system,Spin | 2021-04-28 |
| 2012-11-30 | Class II | Process control | Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification | 1999 | 2015-05-22 |
| 2011-12-19 | Class II | Device Design | The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient. | 10 | 2015-03-23 |
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.