CarboClear Pedicle Screw System
Navigated Pedicle Screw Screwdriver for use with the CarboClear Pedicle Screw System, designed for use with the Medtronic StealthStation® Navigation System.
15manufacturers in China registered for this device type
173catalogue 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) | K173487 |
| Record published | 2019-08-14 |
| Record revised | 2024-11-22 (version 8) |
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, manufacturing date |
| Packaging | Pack of 2, pack of 4 |
| Sizes | Outer diameter 1.2 to 8.5 mm; length 20 to 710 mm; lumen/inner diameter 5 to 8.5 mm |
| Distribution end date | 2024-11-21 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Template – Rod | Length 50 mm | In distribution | |
| Extractor | Lumen/Inner Diameter 6.5 mm | In distribution | |
| Locking Element R45 | 2 | In distribution | |
| Distractor | In distribution | ||
| Holding Forceps | In distribution | ||
| Trans-Connector Rod | Length 30 mm | In distribution | |
| Saw | In distribution | ||
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Probe – Blunt, Curved | In distribution | ||
| Positioning Device | In distribution | ||
| Trans-Connector Locking Element + Ring | In distribution | ||
| Cutting Container | In distribution | ||
| Locking Element Holder | In distribution | ||
| Trans-Connector Rod | Length 52 mm | In distribution | |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Trans-Connector Rod | Length 48 mm | In distribution | |
| Rod – Type 1 | Length 190 mm | In distribution | |
| Navigated Tap 4.5mm | Outer Diameter 4.5 mm | In distribution | |
| Torque Limiter 3.5 Nm | In distribution | ||
| Tap | Outer Diameter 8.0 mm | In distribution | |
| Rod – Type 2 | Outer Diameter 6 mm | In distribution | |
| X-Ray Marker – Left | In distribution | ||
| Extractor | Lumen/Inner Diameter 8.5 mm | In distribution | |
| Rod – Type 4 | Outer Diameter 6 mm | In distribution | |
| Tap | Outer Diameter 7.5 mm | In distribution | |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Trans-Connector Rod | Length 56 mm | In distribution | |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Trans-Connector Rod | Length 36 mm | In distribution | |
| Template – Rod | Length 80 mm | In distribution | |
| Navigated Tap 7.5mm | Outer Diameter 7.5 mm | In distribution | |
| Awl | In distribution | ||
| Guide Wire | Length 710 mm | In distribution | |
| Cutting Set | In distribution | ||
| Trans-Connector Wrench | In distribution | ||
| Tap | Outer Diameter 7.0 mm | In distribution | |
| Persuader | In distribution | ||
| Mallet | In distribution | ||
| Tap | Outer Diameter 5.5 mm | In distribution | |
| Navigated Tap 5.5mm | Outer Diameter 5.5 mm | In distribution | |
| Feeler | In distribution | ||
| Trans-Connector Rod | Length 60 mm | In distribution | |
| Tap | Outer Diameter 6.0 mm | In distribution | |
| Cannula | In distribution | ||
| Template – Rod Type 1 | In distribution | ||
| Template – Rod Type 4 | In distribution | ||
| Probe – Blunt, Straight | In distribution | ||
| Ball Tip Guide Wire | Ball Tip Diameter: 2.5 Millimeter | In distribution | |
| Navigated Probe – Pointed, Straight | In distribution | ||
| Spreader | In distribution | ||
| Trans-Connector Filler Gauge | In distribution | ||
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Patient-Specific Rod | Outer Diameter 6 mm | In distribution | |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Rachet T-Handle | In distribution | ||
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Ti Rod | Outer Diameter 6 mm | In distribution | |
| Unlocker | In distribution | ||
| Trans-Connector Rod | Length 66 mm | In distribution | |
| Navigated Screwdriver | In distribution | ||
| Screwdriver | In distribution | ||
| Straight Rod | Length 65 mm | 2 | In distribution |
| Shaper | In distribution | ||
| Template – Rod Arc | Length 80 mm | In distribution | |
| Compressor | In distribution | ||
| Straight Rod | Length 75 mm | 2 | In distribution |
| Trans-Connector Rod | Length 70 mm | In distribution | |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Tap | Outer Diameter 6.5 mm | In distribution | |
| Navigated Tap 6.0mm | Outer Diameter 6.0 mm | In distribution | |
| Reamer | In distribution | ||
| Unlocker – One Piece | In distribution | ||
| Navigated Probe – Blunt, Straight | In distribution | ||
| Patient Specific Curved Rod | In distribution | ||
| Locking Device | In distribution | ||
| Iliac Crest Rod | Length 100 mm | In distribution | |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Curved Rod | Length 70 mm | 2 | In distribution |
| Ruler | In distribution | ||
| Extractor | Lumen/Inner Diameter 7.5 mm | In distribution | |
| Trans-Connector Unlocker | In distribution | ||
| Template – Rod Arc | Length 50 mm | In distribution | |
| Trans-Connector Rod | Length 40 mm | In distribution | |
| Tap | Outer Diameter 5.0 mm | In distribution | |
| Template – Rod Type 2 | In distribution | ||
| Probe – Pointed, Straight | In distribution | ||
| Rod – Type 5 | Length 270 mm | In distribution | |
| Tulip Adjuster | In distribution | ||
| Extractor | Lumen/Inner Diameter 5.5 mm | In distribution | |
| Navigated Tap 6.5mm | Outer Diameter 6.5 mm | In distribution | |
| Trans-Connector Locking Plier | In distribution | ||
| Navigated Tap 7.0mm | Outer Diameter 7.0 mm | In distribution | |
| Sterilization Case | In distribution | ||
| Trans-Connector Rod | Length 44 mm | In distribution | |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| X-Ray Marker – Left | In distribution | ||
| Tap | Outer Diameter 8.5 mm | In distribution | |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Extractor | Lumen/Inner Diameter 5.0 mm | In distribution | |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| X-Ray Marker – Right | In distribution | ||
| Curved Rod | Length 60 mm | 2 | In distribution |
| Navigated Tap 5.0mm | Outer Diameter 5.0 mm | In distribution | |
| Rod – Type 3 | Length 270 mm | In distribution | |
| Curved Rod | Length 80 mm | 2 | In distribution |
| Locking Element | 2 | In distribution | |
| Probe – Pointed, Curved | In distribution | ||
| Template – Rod Type 3 | In distribution | ||
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Trans-Connector Rod | Outer Diameter 6 mm | In distribution | |
| Trans-Connector Rod | Length 32 mm | In distribution | |
| Tap | Outer Diameter 4.5 mm | In distribution | |
| Pedicle Screw – Cannulated | Length 50 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.0 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Length 40 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 7.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 50 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.0 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 7.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.0 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Length 40 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 35 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Length 55 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Length 40 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 40 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.0 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 65 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 7.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | Withdrawn | |
| Extractor | Lumen/Inner Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Length 75 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Length 95 mm | Withdrawn | |
| Extractor | Lumen/Inner Diameter 5.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Length 35 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 7.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 45 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 55 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 85 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | Withdrawn | |
| Extractor | Lumen/Inner Diameter 7.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.0 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 40 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 45 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 7.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Length 50 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 7.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Length 40 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 35 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Length 50 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.0 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 6.5 mm | Withdrawn | |
| Pedicle Screw – Cannulated | Outer Diameter 8.5 mm | Withdrawn | |
| Pedicle Screw – Non Cannulated | Outer Diameter 5.5 mm | Withdrawn | |
| Pedicle Screw – Fenestrated | Outer Diameter 8.5 mm | Withdrawn |
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.