Mont Blanc MIS Spinal Systems
Mont Blanc MIS polyaxial pedicle screw is a fixation component used with the system's rods and connectors for spinal stabilization as an adjunct to fusion. The MIS screws are cannulated and…
Mont Blanc MIS polyaxial pedicle screw is a fixation component used with the system’s rods and connectors for spinal stabilization as an adjunct to fusion. The MIS screws are cannulated and available in diameters from 4.5 to 8 mm and lengths from 25 to 60 mm.
The screws are implanted through a posterior approach, including percutaneous placement with MIS instrumentation. Implant components are supplied sterile, and the system uses titanium alloy and cobalt-chromium materials.
Listed Item
MIS PEDICLE POLYAXIAL SCREW Ø:4,5 L:30mm
Fusion Applications
Indications include noncervical degenerative disease, spondylolisthesis, trauma, stenosis, deformity, tumor and failed fusion in skeletally mature patients. Pediatric posterior pedicle fixation is limited to adolescent idiopathic scoliosis. The system is used with autograft or allograft.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Shandong (3). 6 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 15. All 15 manufacturers in China registered for Thoracolumbosacral Pedicle Screw System
Record
| Listed by | Spineway SA, France |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| 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 480 mm; outer diameter 4.5 to 8 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | Length 50 mm | 2 | In distribution |
| 1 | Outer Diameter 5 mm | 2 | In distribution |
| 1 | Length 70 mm | 2 | In distribution |
| 1 | Outer Diameter 4.5 mm | 2 | In distribution |
| 1 | Outer Diameter 8 mm | 2 | In distribution |
| 1 | Outer Diameter 6 mm | 2 | In distribution |
| 1 | Outer Diameter 6 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 8 mm | 2 | In distribution |
| 1 | Outer Diameter 7 mm | 2 | In distribution |
| 1 | Outer Diameter 6 mm | 2 | In distribution |
| 1 | Outer Diameter 5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 8 mm | 2 | In distribution |
| 1 | Length 400 mm | 2 | In distribution |
| 1 | Length 130 mm | 2 | In distribution |
| 1 | Length 110 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Length 60 mm | 2 | In distribution |
| 1 | Length 440 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | 2 | In distribution | |
| 1 | Outer Diameter 7 mm | 2 | In distribution |
| 1 | Outer Diameter 7 mm | 2 | In distribution |
| 1 | Length 90 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 7 mm | 2 | In distribution |
| 1 | Outer Diameter 5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 8 mm | 2 | In distribution |
| 1 | Length 480 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Length 80 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Length 360 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 4.5 mm | 2 | In distribution |
| 1 | Length 320 mm | 2 | In distribution |
| 1 | Outer Diameter 5.5 mm | 2 | In distribution |
| 1 | Outer Diameter 4.5 mm | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Jasper Spinal Fixation System | Gbs Commonwealth Co., Ltd. | 32,491 |
| Invictus | Alphatec Spine, Inc. | 4,722 |
| Vital Spinal Fixation System | Highridge Medical, LLC | 4,422 |
| Innoverse Spinal System | CG MedTech Co., Ltd. | 4,240 |
| 4CIS® Chiron Spinal Fixation System | Alpha AI Co., Ltd. | 3,787 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 3,522 |
| Hedjet System | Medyssey Co., Ltd. | 3,438 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 3,424 |
| Mega Plus MIS Spine System | BK Meditech Co., Ltd. | 3,396 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231658 | 2023-10-10 |
| K191726 | 2019-09-12 |
| K161387 | 2016-08-04 |
| K150185 | 2015-05-12 |
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.