Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Tray 2950010 Torque Multiplier Instrumnt
7manufacturers in China registered for this device type
35catalogue numbers in this listing
1510(k) clearance
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 | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K113174 |
| Record published | 2015-07-01 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Sizes | Length 15 to 110 mm; outer diameter 4 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0312658 | Length 90.0 mm | In distribution |
| X0312582 | Length 20.0 mm | In distribution |
| 2950010 | In distribution | |
| X0312532 | Length 65.0 mm | In distribution |
| X0312660 | Length 100.0 mm | In distribution |
| X0312634 | Length 40.0 mm | In distribution |
| X0312510 | Outer Diameter 4.5 mm | In distribution |
| X0312506 | Length 80.0 mm | In distribution |
| X0312572 | Length 30.0 mm | In distribution |
| X0312649 | Length 45.0 mm | In distribution |
| X0312502 | Outer Diameter 4.0 mm | In distribution |
| X0312564 | Length 60.0 mm | In distribution |
| X0312624 | Length 75.0 mm | In distribution |
| X0312617 | Length 40.0 mm | In distribution |
| X0312552 | Length 70.0 mm | In distribution |
| X0312612 | Outer Diameter 8.5 mm | In distribution |
| X0312619 | Length 50.0 mm | In distribution |
| X0312595 | Outer Diameter 8.0 mm | In distribution |
| X0312636 | Length 50.0 mm | In distribution |
| X0312566 | Outer Diameter 7.0 mm | In distribution |
| X0312657 | Length 85.0 mm | In distribution |
| X0312544 | Length 55.0 mm | In distribution |
| X0312655 | Outer Diameter 10.0 mm | In distribution |
| X0312599 | Length 110.0 mm | In distribution |
| X0312600 | Outer Diameter 8.5 mm | In distribution |
| X0312530 | Length 15.0 mm | In distribution |
| X0312605 | Length 65.0 mm | In distribution |
| X0312587 | Length 45.0 mm | In distribution |
| X0312529 | Length 90.0 mm | In distribution |
| X0312536 | Length 15.0 mm | In distribution |
| X0312503 | Length 65.0 mm | In distribution |
| X0312576 | Outer Diameter 7.5 mm | In distribution |
| X0312639 | Length 65.0 mm | In distribution |
| X0312507 | Length 15.0 mm | In distribution |
| X0312571 | Outer Diameter 7.5 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140276 | 2014-03-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2018-07-09 | Class II | Employee error | This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm di | 47 units | 2021-05-07 |
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.