Inertia® Pedicle Screw and Deformity Correxxion® System
CrossLynxx Adjustable Cross Connector, LP 29-39 mm
7manufacturers in China registered for this device type
171catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
Record
| Listed by | Nexxt Spine LLC, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K153453 |
| Record published | 2018-08-23 |
| Record revised | 2023-04-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Sizes | Length 3 to 250 mm; outer diameter 3.5 to 30 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-22-105110 | Friction | In distribution |
| C10-01-17 | In distribution | |
| 10-60-7570 | Outer Diameter 7.5 mm | In distribution |
| I10-26-02 | In distribution | |
| 10-24-LRMD | Medium | In distribution |
| 10-28-CC6494 | In distribution | |
| 10-38-5560 | Length 60 mm | In distribution |
| 10-22-9040 | Friction | In distribution |
| C10-02-11 | In distribution | |
| 10-65-5545 | Length 4.5 mm | In distribution |
| 10-28-CC2939 | In distribution | |
| 10-26-EE5555 | Inline | In distribution |
| 10-44-7570 | Length 70 mm | In distribution |
| 10-22-10590 | Friction | In distribution |
| 10-45-4550 | Length 50 mm | In distribution |
| 10-22-9565 | Friction | In distribution |
| 10-44-6590 | Length 90 mm | In distribution |
| 10-26-DW | Double Open Wedding | In distribution |
| 10-55-55500 | In distribution | |
| 10-22-9075 | Friction | In distribution |
| 10-22-8585 | Friction | In distribution |
| 10-22-8560 | Friction | In distribution |
| 10-60-7525 | Outer Diameter 7.5 mm | In distribution |
| 10-60-6575 | Outer Diameter 6.5 mm | In distribution |
| 10-22-85105 | Friction | In distribution |
| 10-60-6555 | Outer Diameter 6.5 mm | In distribution |
| 10-45-4520 | Length 20 mm | In distribution |
| 10-22-7070 | Friction | In distribution |
| 10-40-7520 | Length 20 mm | In distribution |
| 10-38-55120 | Length 120 mm | In distribution |
| 10-22-90100 | Friction | In distribution |
| I10-28-07 | In distribution | |
| 10-44-7525 | Length 25 mm | In distribution |
| 10-22-9020 | Friction | In distribution |
| 10-40-7590 | Length 90 mm | In distribution |
| 10-45-5530 | Length 30 mm | In distribution |
| 10-24-LLSM | Small | In distribution |
| 10-44-7590 | Length 90 mm | In distribution |
| 10-60-7550 | Outer Diameter 7.5 mm | In distribution |
| 10-40-6545 | Length 45 mm | In distribution |
| 10-22-9050 | Friction | In distribution |
| 10-40-7580 | Length 80 mm | In distribution |
| 10-22-9065 | Friction | In distribution |
| C10-02-04 | In distribution | |
| 10-22-90115 | Friction | In distribution |
| 10-25-C60 | Length 60 mm | In distribution |
| 10-44-7560 | Length 60 mm | In distribution |
| 10-22-9080 | Friction | In distribution |
| 10-22-8550 | Friction | In distribution |
| 10-60-8530 | Outer Diameter 8.5 mm | In distribution |
| 10-60-6565 | Outer Diameter 6.5 mm | In distribution |
| 10-25-C40 | Length 40 mm | In distribution |
| 10-44-4530 | Length 30 mm | In distribution |
| 10-40-4540 | Length 40 mm | In distribution |
| 10-38-55100 | Length 100 mm | In distribution |
| C10-02-10 | In distribution | |
| 10-40-4525 | Length 25 mm | In distribution |
| 10-22-8530 | Friction | In distribution |
| 10-40-6595 | Length 95 mm | In distribution |
| 10-22-7095 | Friction | In distribution |
| 10-44-6550 | Length 50 mm | In distribution |
| 10-60-8565 | Outer Diameter 8.5 mm | In distribution |
| 10-44-6520 | Length 20 mm | In distribution |
| 10-65-5530 | Length 3.0 mm | In distribution |
| I10-06-35CC | Outer Diameter 3.5 mm | In distribution |
| 10-40-6555 | Length 55 mm | In distribution |
| 10-45-4530 | Length 30 mm | In distribution |
| 10-24-LSSM | Small | In distribution |
| 10-22-90105 | Friction | In distribution |
| 10-65-6535 | Length 3.5 mm | In distribution |
| 10-22-6580 | Friction | In distribution |
| 10-22-5560 | Outer Diameter 5.5 mm | In distribution |
| 10-22-7025 | Friction | In distribution |
| 10-22-5525 | Friction | In distribution |
| 10-65-4535 | Length 3.5 mm | In distribution |
| 10-40-7560 | Length 60 mm | In distribution |
| 10-22-85115 | Friction | In distribution |
| 10-26-DW65 | Double Open | In distribution |
| 10-44-6580 | Length 80 mm | In distribution |
| 10-60-75100 | Outer Diameter 7.5 mm | In distribution |
| 10-45-5520 | Length 20 mm | In distribution |
| 10-22-5580 | Outer Diameter 5.5 mm | In distribution |
| 10-60-6535 | Outer Diameter 6.5 mm | In distribution |
| I10-08-10 | In distribution | |
| 10-65-6545 | Length 4.5 mm | In distribution |
| 10-22-9580 | Friction | In distribution |
| 10-60-7590 | Outer Diameter 7.5 mm | In distribution |
| 10-60-7560 | Outer Diameter 7.5 mm | In distribution |
| 10-60-6595 | Outer Diameter 6.5 mm | In distribution |
| 10-22-8575 | Friction | In distribution |
| 10-24-LSLG | Large | In distribution |
| 10-40-6535 | Length 35 mm | In distribution |
| 10-40-7550 | Length 50 mm | In distribution |
| 10-22-10545 | Friction | In distribution |
| 10-40-4550 | Length 50 mm | In distribution |
| 10-65-5555 | Outer Diameter 5.5 mm | In distribution |
| C21-01-07 | In distribution | |
| 10-23-TLLG | Large | In distribution |
| 10-22-9570 | Friction | In distribution |
| 10-65-6555 | Length 5.5 mm | In distribution |
| 10-22-9030 | Friction | In distribution |
| 10-22-7590 | Friction | In distribution |
| 10-45-4540 | Length 40 mm | In distribution |
| C10-02-02 | In distribution | |
| 10-22-9555 | Friction | In distribution |
| 10-40-6565 | Length 65 mm | In distribution |
| 10-44-65100 | Length 100 mm | In distribution |
| 10-44-5550 | Length 50 mm | In distribution |
| 10-44-4520 | Length 20 mm | In distribution |
| 10-22-6570 | Friction | In distribution |
| 10-60-7580 | Outer Diameter 7.5 mm | In distribution |
| 10-22-8520 | Friction | In distribution |
| 10-22-8540 | Friction | In distribution |
| 10-22-7085 | Friction | In distribution |
| 10-40-5540 | Length 40 mm | In distribution |
| 10-22-10570 | Friction | In distribution |
| 10-40-75100 | Length 100 mm | In distribution |
| I10-23-02 | In distribution | |
| 10-44-7580 | Length 80 mm | In distribution |
| 10-40-5530 | Length 30 mm | In distribution |
| 10-44-6545 | Length 45 mm | In distribution |
| 10-22-6595 | Friction | In distribution |
| 10-40-7570 | Length 70 mm | In distribution |
| C10-02-15 | In distribution | |
| 10-60-8595 | Outer Diameter 8.5 mm | In distribution |
| 10-22-9090 | Friction | In distribution |
| 10-40-7540 | Length 40 mm | In distribution |
| 10-22-10555 | Friction | In distribution |
| 10-23-TLSM | Small | In distribution |
| 10-22-5570 | Outer Diameter 5.5 mm | In distribution |
| 10-40-6585 | Length 85 mm | In distribution |
| 10-28-CC4250 | In distribution | |
| 10-22-8595 | Friction | In distribution |
| 10-38-5580 | Length 80 mm | In distribution |
| 10-40-6525 | Length 25 mm | In distribution |
| I10-33-26 | Length 250 mm | In distribution |
| 10-60-7540 | Outer Diameter 7.5 mm | In distribution |
| 10-22-6520 | Friction | In distribution |
| 10-40-6575 | Length 75 mm | In distribution |
| 10-60-6585 | Outer Diameter 6.5 mm | In distribution |
| 10-23-TRMD | Medium | In distribution |
| I10-32-07 | Length 60.4 mm | In distribution |
| 10-60-8575 | Outer Diameter 8.5 mm | In distribution |
| 10-45-4560 | Length 60 mm | In distribution |
| 10-44-5535 | Length 35 mm | In distribution |
| 10-44-5525 | Length 25 mm | In distribution |
| 10-22-8565 | Friction | In distribution |
| 10-65-7540 | Length 4.0 mm | In distribution |
| 10-44-7550 | Length 50 mm | In distribution |
| 10-44-6535 | Length 35 mm | In distribution |
| 10-28-CC2639 | In distribution | |
| 10-60-6545 | Outer Diameter 6.5 mm | In distribution |
| C10-02-13 | In distribution | |
| 10-23-PHMD | Medium | In distribution |
| 10-65-7550 | Length 5.0 mm | In distribution |
| 10-44-7535 | Length 35 mm | In distribution |
| 10-40-5520 | Length 20 mm | In distribution |
| 10-60-8585 | Outer Diameter 8.5 mm | In distribution |
| I10-32-03 | In distribution | |
| 10-44-6570 | Length 70 mm | In distribution |
| 10-22-9590 | Friction | In distribution |
| 10-40-6530 | Length 30 mm | In distribution |
| 10-44-6560 | Length 60 mm | In distribution |
| 10-44-4535 | Outer Diameter 4.5 mm | In distribution |
| 10-44-4545 | Length 45 mm | In distribution |
| 10-60-8535 | Outer Diameter 8.5 mm | In distribution |
| 10-40-5550 | Length 50 mm | In distribution |
| 10-44-75100 | Length 100 mm | In distribution |
| 10-22-9545 | Friction | In distribution |
| I10-28-02 | In distribution | |
| 10-24-LLLG | Large | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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.