CarboClear X Pedicle Screw System
CarboClear X Pedicle Screw System is a family of spinal implants and placement instruments used to build a fixation construct. Its minimally invasive configuration includes pedicle screws,…
CarboClear X Pedicle Screw System is a family of spinal implants and placement instruments used to build a fixation construct. Its minimally invasive configuration includes pedicle screws, rods and locking set screws, with instruments to prepare for and place those implants.
The implants use carbon fiber reinforced PEEK. A thin titanium shell covers the threaded part of the pedicle screws, and some components include tantalum markers. The sterile implants are intended for single use.
Listed Item
An adaptor for the Pedicle Screw Navigated Screwdriver for use with the CarboClear X Pedicle Screw System.
Placement and Screw Options
Navigated instruments work with the Medtronic StealthStation system to locate anatomy during screw preparation and placement. A fenestrated screw configuration has a central passage and openings near the distal tip for delivery of the specified High V+ PMMA bone cement.
15manufacturers in China registered for this device type
115catalogue numbers in this listing
12510(k) clearances naming this product 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 | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K231280 |
| Record published | 2025-05-14 |
| Record revised | 2026-05-04 (version 4) |
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 |
| Packaging | Pack of 2 |
| Sizes | Outer diameter 1.6 to 8.5 mm; length 20 to 95 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution | |
| Rod Reducer | In distribution | ||
| Pedicle Screw – Non Cannulated | Length 50 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 35 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution | |
| MIS Counter Torque | In distribution | ||
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution | |
| Pedicle Screw – Fenestrated | Length 35 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 20 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 30 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 20 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 40 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution | |
| MIS Rod Gauge (Length Forceps) | In distribution | ||
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution | |
| Set Screw Locker | In distribution | ||
| Pedicle Screw – Cannulated | Length 40 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution | |
| Counter-torque | In distribution | ||
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution | |
| Butterfly Handle – MIS | In distribution | ||
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 30 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 50 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 35 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution | |
| Variable Torque Limiter | In distribution | ||
| Pedicle Screw – Non Cannulated | Length 30 mm | In distribution | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 40 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 40 mm | In distribution | |
| Navigated Screwdriver Adaptor | In distribution | ||
| Sterilization Case | In distribution | ||
| Pedicle Screw – Non Cannulated | Length 35 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 35 mm | In distribution | |
| MIS Soft Tissue Dilator | In distribution | ||
| Pedicle Screw – Cannulated | Length 50 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 20 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 40 mm | In distribution | |
| MIS One Step Bone Tap Sleeve 7.5-8.5 mm | In distribution | ||
| MIS Sterilization Box | In distribution | ||
| Pedicle Screw – Cannulated | Length 35 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution | |
| Set Screw Starter | In distribution | ||
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 25 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution | |
| MIS Tube Stopper | In distribution | ||
| Pedicle Screw – Cannulated | Length 55 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 55 mm | In distribution | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | In distribution | |
| MIS Set Screw Locker | In distribution | ||
| MIS Rod Inserter | In distribution | ||
| Tulip Adjuster | In distribution | ||
| Screw Block | In distribution | ||
| Pedicle Screw – Cannulated | Length 75 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | In distribution | |
| MIS One Step Bone Tap Sleeve 5.5 mm | In distribution | ||
| Pedicle Screw – Cannulated | Length 95 mm | In distribution | |
| MIS One Step Sliding Stylet | Outer Diameter 1.6 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 55 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 40 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 40 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution | |
| Navigated Screwdriver | In distribution | ||
| MIS Rod Inserter Screwdriver | In distribution | ||
| Pedicle Screw – Non Cannulated | Length 35 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 85 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 55 mm | In distribution | |
| MIS Distractor/Compressor | In distribution | ||
| Pedicle Screw – Non Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Fenestrated | Length 40 mm | In distribution | |
| Rod Pusher | In distribution | ||
| MIS Rod Feeler | In distribution | ||
| MIS One Step Bone Tap Sleeve 5.0 mm | In distribution | ||
| Pedicle Screw – Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 25 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 55 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 40 mm | In distribution | |
| MIS Screw Tube | In distribution | ||
| Screwdriver | In distribution | ||
| Locking Element – Set Screw | 2 | In distribution | |
| MIS One Step Bone Tap Sleeve 6.5 mm | In distribution | ||
| Pedicle Screw – Cannulated | Length 35 mm | In distribution | |
| Pedicle Screw – Cannulated | Outer Diameter 8.5 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 50 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution | |
| Rod Reducer Handle | In distribution | ||
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 45 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution | |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution | |
| Pedicle Screw – Non Cannulated | Length 50 mm | 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 |
|---|---|
| K243106 | 2024-11-05 |
| K233793 | 2024-08-01 |
| K240846 | 2024-04-25 |
| K233944 | 2024-01-10 |
| K232341 | 2023-10-10 |
| K231280 | 2023-07-03 |
| K210716 | 2021-04-06 |
| K203317 | 2020-11-25 |
| K201926 | 2020-08-07 |
| K200519 | 2020-04-30 |
| K182377 | 2018-09-27 |
| K173487 | 2018-07-18 |
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.