CarboClear Pedicle Screw Systems
Straight Rod of the CarboClear X Pedicle Screw System (MIS)
5manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Manufacturer |
| 510(k) | K231280 |
| Record published | 2023-09-19 |
| Record revised | 2024-05-30 (version 3) |
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 6 mm; length 35 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Curved Rod | Outer Diameter 6 mm | 2 | In distribution |
| Straight Rod | Outer Diameter 6 mm | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201251 | 2020-08-05 |
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.