Mont Blanc MIS Spinal Systems
MIS PEDICLE POLYAXIAL SCREW Ø:4,5 L:55mm
7manufacturers in China registered for this device type
35catalogue 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 | Spineway SA, France |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K161387 |
| Record published | 2016-08-08 |
| Record revised | 2025-07-02 (version 4) |
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 |
| Sizes | Length 25 to 280 mm; outer diameter 4.5 to 8 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | Length 90 mm | 2 | In distribution |
| 1 | Length 45 mm | 2 | In distribution |
| 1 | Length 30 mm | 2 | In distribution |
| 1 | Length 70 mm | 2 | In distribution |
| 1 | Length 200 mm | 2 | In distribution |
| 1 | Length 140 mm | 2 | In distribution |
| 1 | Length 115 mm | 2 | In distribution |
| 1 | Length 55 mm | 2 | In distribution |
| 1 | Length 40 mm | 2 | In distribution |
| 1 | Length 130 mm | 2 | In distribution |
| 1 | Length 35 mm | 2 | In distribution |
| 1 | Length 110 mm | 2 | In distribution |
| 1 | Length 135 mm | 2 | In distribution |
| 1 | Length 30 mm | 2 | In distribution |
| 1 | Length 50 mm | 2 | In distribution |
| 1 | Length 55 mm | 2 | In distribution |
| 1 | Length 55 mm | 2 | In distribution |
| 1 | Length 35 mm | 2 | In distribution |
| 1 | Length 40 mm | 2 | In distribution |
| 1 | Length 25 mm | 2 | In distribution |
| 1 | Length 280 mm | 2 | In distribution |
| 1 | Length 75 mm | 2 | In distribution |
| 1 | Length 45 mm | 2 | In distribution |
| 1 | Length 40 mm | 2 | In distribution |
| 1 | Length 160 mm | 2 | In distribution |
| 1 | Length 95 mm | 2 | In distribution |
| 1 | Length 25 mm | 2 | In distribution |
| 1 | Length 50 mm | 2 | In distribution |
| 1 | Length 240 mm | 2 | In distribution |
| 1 | Length 25 mm | 2 | In distribution |
| 1 | Length 45 mm | 2 | In distribution |
| 1 | Length 180 mm | 2 | In distribution |
| 1 | Length 35 mm | 2 | In distribution |
| 1 | Length 55 mm | 2 | In distribution |
| 1 | Length 50 mm | 2 | 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.