Mega Plus MIS Spine System
Mega Plus MIS is a spinal fixation system made up of pedicle screws, rods, locking bolts and transverse links. The components form a posterior construct that stabilizes spinal segments as…
Mega Plus MIS is a spinal fixation system made up of pedicle screws, rods, locking bolts and transverse links. The components form a posterior construct that stabilizes spinal segments as an adjunct to fusion.
The top-loading system allows the rod to be secured within the screw assembly by a locking bolt. Different implant sizes and connector components support construction of the selected fixation layout.
Listed Item
Long-arm Multi-Axial Fenestrated Screw, Ø10.5 x 100mm, Ø6.0mm Rod
Approach and Material Options
The system supports open and percutaneous minimally invasive approaches. Its implant range includes titanium alloy and cobalt-chromium-molybdenum alloy components supplied nonsterile. Fenestrated screw options in this system are intended for saline or radiopaque dye, rather than bone-cement delivery.
15manufacturers in China registered for this device type
3,396catalogue numbers in this listing
3510(k) clearances naming this product code
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 | BK Meditech Co., Ltd., South Korea |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K200981 |
| Record published | 2021-08-31 |
| Record revised | 2024-09-11 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69405-75 | In distribution | |
| 98185-55 | In distribution | |
| 69805-95 | In distribution | |
| 97170-30 | In distribution | |
| 97665-35 | In distribution | |
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| 97585-90 | In distribution | |
| 69131-400 | In distribution | |
| 93605-65 | In distribution | |
| 98185-50 | In distribution | |
| 97270-45 | In distribution | |
| 94685-30 | In distribution | |
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| 69405-30 | In distribution | |
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| 97505-40 | In distribution | |
| 69131-100 | In distribution | |
| 69130-230 | In distribution | |
| 69545-25 | In distribution | |
| 69785-40 | In distribution | |
| 69120-270 | In distribution | |
| 69185-50 | In distribution | |
| 94965-35 | In distribution | |
| 97270-60 | In distribution | |
| 69221-045 | In distribution | |
| 98575-55 | In distribution | |
| 69120-090 | In distribution | |
| 97595-55 | In distribution | |
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| 97105-65 | In distribution | |
| 69495-35 | In distribution | |
| 69885-80 | In distribution | |
| 98505-55 | In distribution | |
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| 94785-75 | In distribution | |
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| 98705-70 | In distribution | |
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| 97995-70 | In distribution | |
| 97160-50 | In distribution | |
| 97655-55 | In distribution | |
| 69220-270 | In distribution | |
| 98695-80 | In distribution | |
| 69155-60 | In distribution | |
| 69130-250 | In distribution | |
| 97705-90 | In distribution | |
| 93765-50 | In distribution | |
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| 93685-65 | In distribution | |
| 98655-45 | In distribution | |
| 69170-60 | In distribution | |
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| 69805-75 | In distribution | |
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| 69231-100 | In distribution | |
| 98745-25 | In distribution | |
| 98705-80 | In distribution | |
| 97985-50 | In distribution | |
| 94650-40 | In distribution | |
| 97465-60 | In distribution | |
| 93760-55 | In distribution | |
| 97845-35 | In distribution | |
| 97805-90 | In distribution | |
| 69605-45 | In distribution | |
| 69130-070 | In distribution | |
| 69230-090 | In distribution | |
| 98685-60 | In distribution | |
| 97160-45 | In distribution | |
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| 69121-300 | In distribution | |
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| 97170-45 | In distribution | |
| 97455-30 | In distribution | |
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| 97195-50 | In distribution | |
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| 69231-260 | In distribution | |
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| 98245-50 | In distribution | |
| 69131-075 | In distribution | |
| 69495-60 | In distribution | |
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| 69121-100 | In distribution | |
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| 69605-90 | In distribution | |
| 69205-60 | In distribution | |
| 69170-35 | In distribution | |
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| 98250-55 | In distribution | |
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Showing 250 of 300 catalogue numbers.
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 |
| ReLine | Nuvasive, Inc. | 2,882 |
| Nex-D2 | Next Orthosurgical | 2,765 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 2,386 |
| Vital™ | Biomet Spine | 2,355 |
Showing 12 of 1,490. All products under Thoracolumbosacral Pedicle Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200981 | 2020-08-11 |
| K183080 | 2018-12-10 |
| K173180 | 2018-03-15 |
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.