Orthros MIS
ORTHROS MIS is a posterior spinal stabilization system with cannulated polyaxial screws, rods and locking set screws. Screws anchor in vertebral bone, and rods connect them into a rigid…
ORTHROS MIS is a posterior spinal stabilization system with cannulated polyaxial screws, rods and locking set screws. Screws anchor in vertebral bone, and rods connect them into a rigid construct used as an adjunct to fusion.
The MIS implants are titanium alloy and come in different shapes and sizes. Locking set screws secure the rods to the screw assemblies, while manual instruments support percutaneous placement.
Listed Item
Ø7.5mm Cannulated MIS Polyaxial Pedicle Screw, 105mm Lg. Long Tower
MIS Configuration
The MIS screw configuration is intended for posterior use. Its rods, percutaneous screws and instruments form a specific subset of the broader ORTHROS range, and the implants are supplied nonsterile for user sterilization.
15manufacturers in China registered for this device type
244catalogue numbers in this listing
2510(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 | Camber Spine Technologies, United States |
|---|---|
| FDA product code | NKB |
| Device type | Thoracolumbosacral Pedicle Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180980 |
| Record published | 2024-05-16 |
| Record revised | 2024-09-11 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 25 to 160 mm; outer diameter 5.5 mm |
| Distribution end date | 2024-08-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ORM-1-5525L | In distribution | |
| ORM-1-7540L | In distribution | |
| ORM-6550 | In distribution | |
| ORM-1-7585 | In distribution | |
| ORM-1-6530 | In distribution | |
| ORM-1-8585L | In distribution | |
| ORM-1-5565L | In distribution | |
| ORM-1-7560 | In distribution | |
| ORM-1-7535 | In distribution | |
| ORM-1-8560 | In distribution | |
| ORM-1-8565L | In distribution | |
| ORM-1-8535 | In distribution | |
| ORM-1-5565 | In distribution | |
| ORM-8540L | Length 40 mm | In distribution |
| ORM-6535L | Length 35 mm | In distribution |
| ORM-1-6585L | In distribution | |
| ORM-1-8530 | In distribution | |
| ORM-1-7555 | In distribution | |
| ORM-1-7555L | In distribution | |
| ORM-8580L | Length 80 mm | In distribution |
| ORM-1-6590L | In distribution | |
| ORM-8535 | Length 35 mm | In distribution |
| ORM-7590L | Length 90 mm | In distribution |
| ORM-7560L | Length 60 mm | In distribution |
| ORM-6540 | Length 40 mm | In distribution |
| ORM-85C | Length 85 mm | In distribution |
| ORM-8545 | Length 45 mm | In distribution |
| ORM-1-7525L | In distribution | |
| ORM-1-6535L | In distribution | |
| ORM-1-8585 | In distribution | |
| ORM-1-7570L | In distribution | |
| ORM-7545L | Length 45 mm | In distribution |
| ORM-1-7550L | In distribution | |
| ORM-1-8530L | In distribution | |
| ORM-1-85110 | In distribution | |
| ORM-1-8570L | In distribution | |
| ORM-6560L | Length 60 mm | In distribution |
| ORM-1-8550L | In distribution | |
| ORM-5530L | Length 30 mm | In distribution |
| ORM-7555L | Length 55 mm | In distribution |
| ORM-1-5530L | In distribution | |
| ORM-1-75100L | In distribution | |
| ORM-1-5530 | In distribution | |
| ORM-1-6535 | In distribution | |
| ORM-7580L | Length 80 mm | In distribution |
| ORM-1-5575L | In distribution | |
| ORM-5535 | Length 35 mm | In distribution |
| ORM-1-85100L | In distribution | |
| ORM-7555 | Length 55 mm | In distribution |
| ORM-8585 | Length 85 mm | In distribution |
| ORM-1-6585 | In distribution | |
| ORM-1-8595 | In distribution | |
| ORM-1-5570L | In distribution | |
| ORM-55C | Length 55 mm | In distribution |
| ORM-5550L | Length 50 mm | In distribution |
| ORM-5545 | Length 45 mm | In distribution |
| ORM-7575L | Length 75 mm | In distribution |
| ORM-6530L | Length 30 mm | In distribution |
| ORM-5555L | Length 55 mm | In distribution |
| ORM-8575L | Length 75 mm | In distribution |
| ORM-8530L | Length 30 mm | In distribution |
| ORM-1-8525 | In distribution | |
| ORM-1-75105L | In distribution | |
| ORM-75105 | Length 105 mm | In distribution |
| ORM-1-8590L | In distribution | |
| ORM-1-8555 | In distribution | |
| ORM-1-7575 | In distribution | |
| ORM-1-7595 | In distribution | |
| ORM-1-8560L | In distribution | |
| ORM-1-7585L | In distribution | |
| ORM-6545L | Length 45 mm | In distribution |
| ORM-5555 | Length 55 mm | In distribution |
| ORM-1-65100 | In distribution | |
| ORM-1-8590 | In distribution | |
| ORM-5525L | Length 25 mm | In distribution |
| ORM-1-6570L | In distribution | |
| ORM-8580 | Length 80 mm | In distribution |
| ORM-1-6540 | In distribution | |
| ORM-6555L | Length 55 mm | In distribution |
| ORM-1-6575L | In distribution | |
| ORM-7540 | Length 40 mm | In distribution |
| ORM-8535L | Length 35 mm | In distribution |
| ORM-1-7530 | In distribution | |
| ORM-1-6550 | In distribution | |
| ORM-75100 | Length 100 mm | In distribution |
| ORM-145C | Length 145 mm | In distribution |
| ORM-85105 | Length 105 mm | In distribution |
| ORM-1-8570 | In distribution | |
| ORM-1-65110 | In distribution | |
| ORM-1-85105L | In distribution | |
| ORM-1-65105L | In distribution | |
| ORM-1-7545 | In distribution | |
| ORM-7575 | Length 75 mm | In distribution |
| ORM-1-6565 | In distribution | |
| ORM-1-8545 | In distribution | |
| ORM-1-75100 | In distribution | |
| ORM-85100 | Length 100 mm | In distribution |
| ORM-1-5540L | In distribution | |
| ORM-1-5545L | In distribution | |
| ORM-7535 | Length 35 mm | In distribution |
| ORM-7550 | Length 50 mm | In distribution |
| ORM-1-5535 | In distribution | |
| ORM-1-5555L | In distribution | |
| ORM-7530 | Length 30 mm | In distribution |
| ORM-1-7560L | In distribution | |
| ORM-5540 | Length 40 mm | In distribution |
| ORM-1-7570 | In distribution | |
| ORM-5525 | Length 25 mm | In distribution |
| ORM-1-7580 | In distribution | |
| ORM-7570 | Length 70 mm | In distribution |
| ORM-1-6550L | In distribution | |
| ORM-1-5560 | In distribution | |
| ORM-1-8540 | In distribution | |
| ORM-6555 | Length 55 mm | In distribution |
| ORM-5550 | Length 50 mm | In distribution |
| ORM-6560 | Length 60 mm | In distribution |
| ORM-1-8550 | In distribution | |
| ORM-1-6580 | In distribution | |
| ORM-1-5535L | In distribution | |
| ORM-95C | Length 95 mm | In distribution |
| ORM-8595 | Length 95 mm | In distribution |
| ORM-135C | Length 135 mm | In distribution |
| ORM-6540L | Length 40 mm | In distribution |
| ORM-1-8535L | In distribution | |
| ORM-8550 | Length 50 mm | In distribution |
| ORM-1-75110L | In distribution | |
| ORM-7595 | Length 95 mm | In distribution |
| ORM-8590 | Length 90 mm | In distribution |
| ORM-1-6595 | In distribution | |
| ORM-8560L | Length 60 mm | In distribution |
| ORM-1-5550 | In distribution | |
| ORM-6545 | Length 45 mm | In distribution |
| ORM-105C | Length 105 mm | In distribution |
| ORM-8595L | Length 95 mm | In distribution |
| ORM-1-75110 | In distribution | |
| ORM-1-8595L | In distribution | |
| ORM-1-8580L | In distribution | |
| ORM-7565 | Length 65 mm | In distribution |
| ORM-75105L | Length 105 mm | In distribution |
| ORM-8530 | Length 30 mm | In distribution |
| ORM-1-6565L | In distribution | |
| ORM-1-8555L | In distribution | |
| ORM-8555L | Length 55 mm | In distribution |
| ORM-85110L | Length 110 mm | In distribution |
| ORM-6550L | Length 50 mm | In distribution |
| ORM-1-75105 | In distribution | |
| ORM-1-7565 | In distribution | |
| ORM-8565L | Length 65 mm | In distribution |
| ORM-8545L | Length 45 mm | In distribution |
| ORM-75110 | Length 110 mm | In distribution |
| ORM-1-5580 | In distribution | |
| ORM-8585L | Length 85 mm | In distribution |
| ORM-35C | Length 35 mm | In distribution |
| CM-002-10 | In distribution | |
| ORM-1-5575 | In distribution | |
| ORM-6530 | Length 30 mm | In distribution |
| ORM-1-5545 | In distribution | |
| ORM-1-6545L | In distribution | |
| ORM-5530 | Length 30 mm | In distribution |
| ORM-7580 | Length 80 mm | In distribution |
| ORM-7560 | Length 60 mm | In distribution |
| ORM-1-7580L | In distribution | |
| ORM-8540 | Length 40 mm | In distribution |
| ORM-1-8540L | In distribution | |
| ORM-8565 | Length 65 mm | In distribution |
| ORM-1-65110L | In distribution | |
| ORM-5535L | Length 35 mm | In distribution |
| ORM-1-5570 | In distribution | |
| ORM-5540L | Length 40 mm | In distribution |
| ORM-1-7530L | In distribution | |
| ORM-7590 | Length 90 mm | In distribution |
| ORM-85100L | Length 100 mm | In distribution |
| ORM-1-7575L | In distribution | |
| ORM-1-7540 | In distribution | |
| ORM-1-8565 | In distribution | |
| ORM-7530L | Length 30 mm | In distribution |
| ORM-1-65105 | In distribution | |
| ORM-1-7525 | In distribution | |
| ORM-1-5555 | In distribution | |
| ORM-6565 | Length 65 mm | In distribution |
| ORM-1-7595L | In distribution | |
| ORM-5545L | Length 45 mm | In distribution |
| ORM-7550L | Length 50 mm | In distribution |
| ORM-1-7590L | In distribution | |
| ORM-8560 | Length 60 mm | In distribution |
| ORM-1-6540L | In distribution | |
| ORM-125C | Length 125 mm | In distribution |
| ORM-1-6560L | In distribution | |
| ORM-1-6555 | In distribution | |
| ORM-1-85105 | In distribution | |
| ORM-1-8525L | In distribution | |
| ORM-75C | Length 75 mm | In distribution |
| ORM-8550L | Length 50 mm | In distribution |
| ORM-1-6570 | In distribution | |
| ORM-7535L | Length 35 mm | In distribution |
| ORM-7585L | Length 85 mm | In distribution |
| ORM-1-6525 | In distribution | |
| ORM-1-6595L | In distribution | |
| ORM-6565L | Length 65 mm | In distribution |
| ORM-7570L | Length 70 mm | In distribution |
| ORM-1-6560 | In distribution | |
| ORM-8590L | Length 90 mm | In distribution |
| ORM-1-5560L | In distribution | |
| ORM-8555 | Length 55 mm | In distribution |
| ORM-65C | Length 65 mm | In distribution |
| ORM-75110L | Length 110 mm | In distribution |
| ORM-1-65100L | In distribution | |
| ORM-1-6530L | In distribution | |
| ORM-1-6555L | In distribution | |
| ORM-1-85100 | In distribution | |
| ORM-7595L | Length 95 mm | In distribution |
| ORM-85105L | Length 105 mm | In distribution |
| ORM-45C | Length 45 mm | In distribution |
| ORM-1-7545L | In distribution | |
| ORM-1-5550L | In distribution | |
| ORM-7565L | Length 65 mm | In distribution |
| ORM-8570L | Length 70 mm | In distribution |
| ORM-1-8580 | In distribution | |
| ORM-8575 | Length 75 mm | In distribution |
| ORM-1-8545L | In distribution | |
| ORM-1-5540 | In distribution | |
| ORM-8570 | Length 70 mm | In distribution |
| ORM-1-7535L | In distribution | |
| ORM-1-6545 | In distribution | |
| ORM-7540L | Length 40 mm | In distribution |
| ORM-6535 | Length 35 mm | In distribution |
| ORM-160C | Length 160 mm | In distribution |
| ORM-1-7590 | In distribution | |
| ORM-1-6525L | In distribution | |
| ORM-1-5580L | In distribution | |
| ORM-1-8575L | In distribution | |
| ORM-7545 | Length 45 mm | In distribution |
| ORM-1-85110L | In distribution | |
| ORM-85110 | Length 110 mm | In distribution |
| ORM-1-6590 | In distribution | |
| ORM-1-6580L | In distribution | |
| ORM-1-5525 | In distribution | |
| ORM-115C | Length 115 mm | In distribution |
| ORM-75100L | Length 100 mm | In distribution |
| ORM-1-6575 | In distribution | |
| ORM-7585 | Length 85 mm | In distribution |
| ORM-1-7550 | In distribution | |
| ORM-1-8575 | In distribution | |
| ORM-1-7560L | Withdrawn |
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 |
|---|---|
| K180980 | 2018-10-27 |
| K133366 | 2014-04-08 |
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.