CarboClear Hybrid Pedicle Screw System
Set Screw Locker for use with the CarboClear Hybrid Pedicle Screw System
2manufacturers in China registered for this device type
153catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | PML |
| Device type | Bone Cement, Posterior Screw Augmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3027 |
| Establishment | Manufacturer |
| 510(k) | K240846 |
| Record published | 2025-04-03 |
| Record revised | 2025-03-11 (version 3) |
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 | Length 20 to 55 mm; outer diameter 5 to 7.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| Distractor-Compressor | In distribution | |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 55 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 35 mm | In distribution |
| MIS Pedicle Screw | Length 30 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 55 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 30 mm | In distribution |
| MIS Pedicle Screw | Length 55 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.5 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 45 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.5 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 20 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 40 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.0 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 35 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 20 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.5 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.0 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 55 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.0 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.0 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 50 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 30 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 45 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 20 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 40 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 35 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 50 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 25 mm | In distribution |
| MIS Pedicle Screw | Length 50 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.0 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.5 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 55 mm | In distribution |
| Distractor-Compressor | In distribution | |
| Pedicle Screw – Dual Thread | Length 50 mm | In distribution |
| MIS Pedicle Screw | Length 30 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| MIS Pedicle Screw | Length 50 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 50 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution |
| MIS Pedicle Screw | Length 55 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| MIS Pedicle Screw | Length 55 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| MIS Pedicle Screw | Length 55 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 50 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 30 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 30 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.0 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 25 mm | In distribution |
| MIS Pedicle Screw | Length 50 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| Distractor-Compressor | In distribution | |
| MIS Pedicle Screw | Length 20 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 25 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 50 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 30 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 55 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 50 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 30 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 35 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 25 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 55 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
| MIS Pedicle Screw | Length 40 mm | In distribution |
| Locker | In distribution | |
| MIS Dual Thread Pedicle Screw | Length 40 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 45 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 55 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 40 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 35 mm | In distribution |
| MIS Dual Thread Pedicle Screw | Length 50 mm | In distribution |
| Pedicle Screw – Fenestrated | Length 40 mm | In distribution |
| Pedicle Screw – Dual Thread | Length 35 mm | In distribution |
| MIS Pedicle Screw | Length 45 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 321 |
| M.u.s.t. Pedicle Screw System | Medacta International SA | 248 |
| Viper | Medos International Sàrl | 32 |
| Expedium Verse | Medos International Sàrl | 26 |
| CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 18 |
| Vader Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 x 55 mm | Icotec AG | 13 |
| CarboClear Modular Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 11 |
| CarboClear Pedicle Screw System | CarboFix Orthopedics, Ltd. | 9 |
| icotec Pedicle System, Screw, Ti, Polyax., Fen., Ø 8.5 x 45 mm | Icotec AG | 6 |
| Vader Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 | Icotec AG | 1 |
| Romeo® 2 | Spineart SA | 1 |
| Vader Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm | Icotec AG | 1 |
Showing 12 of 14. All products under Bone Cement, Posterior Screw Augmentation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190526 | 2019-09-19 |
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.