MIS Polyaxial Pedicle Screw
Ø6.5mm mis cannulated polyaxial pedicle screw , 60mm Lg.
15manufacturers in China registered for this device type
84catalogue 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) | K133366 |
| Record published | 2016-10-19 |
| Record revised | 2024-10-18 (version 6) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CM-006-14 | Ø6.5mm x 60mm Lg. | In distribution |
| CM-006-06 | Ø5.5mm x 50mm Lg. | In distribution |
| CM-009-00 | Ø5.5mm x 25mm Lg. | In distribution |
| CM-009-25 | Ø5.5mm x 160mm Lg. | In distribution |
| CM-009-03 | Ø5.5mm x 45mm Lg. | In distribution |
| CM-009-30 | Ø5.5mm x 30mm Lg. | In distribution |
| CM-009-23 | Ø5.5mm x 145mm Lg. | In distribution |
| CM-009-26 | Ø5.5mm x 180mm Lg. | In distribution |
| CM-009-04 | Ø5.5mm x 50mm Lg. | In distribution |
| CM-009-15 | Ø5.5mm x 105mm Lg. | In distribution |
| CM-006-01 | Ø5.5mm x 25mm Lg. | In distribution |
| CM-006-44 | Ø8.5mm x 85mm Lg. | In distribution |
| CM-009-14 | Ø5.5mm x 100mm Lg. | In distribution |
| CM-006-39 | Ø8.5mm x 60mm Lg. | In distribution |
| CM-006-23 | Ø7.5mm x 60mm Lg. | In distribution |
| CM-006-02 | Ø5.5mm x 30mm Lg. | In distribution |
| CM-006-21 | Ø7.5mm x 55mm Lg. | In distribution |
| CM-006-04 | Ø5.5mm x 40mm Lg. | In distribution |
| CM-006-46 | Ø8.5mm x 95mm Lg. | In distribution |
| CM-006-47 | Ø8.5mm x 100mm Lg. | In distribution |
| CM-006-15 | Ø6.5mm x 65mm Lg. | In distribution |
| CM-009-24 | Ø5.5mm x 150mm Lg. | In distribution |
| CM-009-02 | Ø5.5mm x 40mm Lg. | In distribution |
| CM-009-18 | Ø5.5mm x 120mm Lg. | In distribution |
| CM-006-48 | Ø8.5mm x 105mm Lg. | In distribution |
| CM-006-32 | Ø7.5mm x 110mm Lg. | In distribution |
| CM-006-36 | Ø8.5mm x 45mm Lg. | In distribution |
| CM-006-05 | Ø5.5mm x 45mm Lg. | In distribution |
| CM-006-07 | Ø5.5mm x 55mm Lg. | In distribution |
| CM-009-31 | Ø5.5mm x 20mm Lg. | In distribution |
| CM-009-11 | Ø5.5mm x 85mm Lg. | In distribution |
| CM-009-10 | Ø5.5mm x 80mm Lg. | In distribution |
| CM-009-17 | Ø5.5mm x 115mm Lg. | In distribution |
| CM-008-04 | Ø5.5mm x 400mm Lg. | In distribution |
| CM-009-01 | Ø5.5mm x 35mm Lg.. | In distribution |
| CM-009-05 | Ø5.5mm x 55mm Lg. | In distribution |
| CM-006-37 | Ø8.5mm x 50mm Lg. | In distribution |
| CM-009-13 | Ø5.5MM X 95MM Lg. | In distribution |
| CM-006-41 | Ø8.5mm x 70mm Lg. | In distribution |
| CM-009-12 | Ø5.5mm x 90mm Lg. | In distribution |
| CM-009-22 | Ø5.5mm x 140mm Lg. | In distribution |
| CM-006-42 | Ø8.5mm x 75mm Lg. | In distribution |
| CM-006-29 | Ø7.5mm x 95mm Lg. | In distribution |
| CM-006-38 | Ø8.5mm x 55mm Lg. | In distribution |
| CM-008-02 | Ø5.5mm x 200mm Lg. | In distribution |
| CM-009-27 | Ø5.5mm x 160mmLg. T | In distribution |
| CM-006-10 | Ø6.5mm x 40mm Lg. | In distribution |
| CM-006-20 | Ø7.5mm x 50mm Lg. | In distribution |
| CM-009-07 | Ø5.5mm x 65mm Lg. | In distribution |
| CM-006-08 | Ø6.5mm x 30mm Lg. | In distribution |
| CM-006-40 | Ø8.5mm x 65mm Lg. | In distribution |
| CM-006-12 | Ø6.5mm x 50mm Lg. | In distribution |
| CM-006-26 | Ø7.5mm x 80mm Lg. | In distribution |
| CM-006-31 | Ø7.5mm x 105mm Lg. | In distribution |
| CM-006-09 | Ø6.5mm x 35mm Lg. | In distribution |
| CM-006-33 | Ø8.5mm x 30mm Lg. | In distribution |
| CM-006-03 | Ø5.5mm x 35mm Lg. | In distribution |
| CM-006-18 | Ø7.5mm x 40mm Lg. | In distribution |
| CM-008-01 | Ø5.5mm x 150mm Lg. | In distribution |
| CM-006-17 | Ø7.5mm x 35mm Lg. | In distribution |
| CM-006-11 | Ø6.5mm x 45mm Lg. | In distribution |
| CM-008-03 | Ø5.5mm x 300mm Lg. | In distribution |
| CM-006-45 | Ø8.5mm x 90mm Lg. | In distribution |
| CM-009-09 | Ø5.5mm x 75mm Lg. | In distribution |
| CM-006-28 | Ø7.5mm x 90mm Lg. | In distribution |
| CM-006-13 | Ø6.5mm x 55mm Lg. | In distribution |
| CM-006-30 | Ø7.5mm x 100mm Lg. | In distribution |
| CM-006-27 | Ø7.5mm x 85mm Lg. | In distribution |
| CM-009-06 | Ø5.5mm x 60mm Lg. | In distribution |
| CM-009-21 | Ø5.5mm x 135mm Lg. | In distribution |
| CM-009-16 | Ø5.5mm x 110mm Lg. | In distribution |
| CM-006-35 | Ø8.5mm x 40mm Lg. | In distribution |
| CM-006-49 | Ø805mm x 110mm Lg. | In distribution |
| CM-009-20 | Ø5.5mm x 130mm Lg. | In distribution |
| CM-009-08 | Ø5.5mm x 70mm Lg. | In distribution |
| CM-006-19 | Ø7.5mm x 45mm Lg. | In distribution |
| CM-006-24 | Ø7.5mm x 70mm Lg. | In distribution |
| CM-006-16 | Ø7.5mm x 30mm Lg. | In distribution |
| CM-006-25 | Ø7.5mm x 75mm Lg. | In distribution |
| CM-006-34 | Ø8.5mm x 35mm Lg. | In distribution |
| CM-006-22 | Ø7.5mm x 60mm Lg. | In distribution |
| CM-009-19 | Ø5.5mm x 125mm Lg. | In distribution |
| CM-006-43 | Ø8.5mm x 80mm Lg. | In distribution |
| CM-009-28 | Ø5.5MM X 180mm Lg. T | 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 |
|---|---|
| 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.