CarboClear Modular Hybrid Pedicle Screw System
CarboClear Modular Hybrid Pedicle Screw System - Fenestrated Screw
2manufacturers in China registered for this device type
11catalogue 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 | 2025-05-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 2 |
| Sizes | Outer diameter 5.5 to 7.5 mm; length 35 to 55 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 5.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 6.5 mm | In distribution |
| Pedicle Screw | Outer Diameter 7.5 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 |
| CarboClear Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 153 |
| 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 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.