Orthros
Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 110mm Lg.
14manufacturers in China registered for this device type
61catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
Showing 12 of 14. All 14 manufacturers in China registered for Appliance, Fixation, Spinal Intervertebral Body
Record
| Listed by | Camber Spine Technologies, United States |
|---|---|
| FDA product code | KWQ |
| Device type | Appliance, Fixation, Spinal Intervertebral Body |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K133366 |
| Record published | 2016-11-03 |
| Record revised | 2024-10-18 (version 7) |
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 |
| Sizes | Outer diameter 5.5 to 8.5 mm; length 30 to 145 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ORO-8595R | Outer Diameter 8.5 mm | In distribution |
| .Ø7.5mm Monoaxial Pedicle Screw, 75mm Lg. | In distribution | |
| Ø5.5mm Cannulated Polyaxial Pedicle Screw, 25mm Lg. | In distribution | |
| Ø8.5mm Polyaxial Pedicle Screw, 35mm Lg. | In distribution | |
| ORO-5535R | Outer Diameter 5.5 mm | In distribution |
| Ø7.5mm Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| CP-008-32 | Length 115 mm | In distribution |
| ORO-75110R | Outer Diameter 7.5 mm | In distribution |
| Ø6.5mm Polyaxial Pedicle Screw, 65mm Lg. | In distribution | |
| Ø7.5mm Polyaxial Pedicle Screw, 45mm Lg. | In distribution | |
| Ø8.5mm Monoaxial Pedicle Screw, 50mm Lg. | In distribution | |
| ORO-5555R | Outer Diameter 5.5 mm | In distribution |
| ORO-8575R | Outer Diameter 8.5 mm | In distribution |
| ORO-5545R | Outer Diameter 5.5 mm | In distribution |
| ORO-7555R | Outer Diameter 7.5 mm | In distribution |
| ORO-6565R | Outer Diameter 6.5 mm | In distribution |
| ORO-8550R | Outer Diameter 8.5 mm | In distribution |
| Ø6.5mm Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 110mm Lg. | In distribution | |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 65mm Lg. | In distribution | |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 105mm Lg. | In distribution | |
| Ø8.5mm Polyaxial Pedicle Screw, 90mm Lg. | In distribution | |
| ORO-8565R | Outer Diameter 8.5 mm | In distribution |
| ORO-85100R | Outer Diameter 8.5 mm | In distribution |
| ORO-7575R | Outer Diameter 7.5 mm | In distribution |
| ORO-85110R | Outer Diameter 8.5 mm | In distribution |
| ORO-8570R | Outer Diameter 8.5 mm | In distribution |
| Ø5.5mm Monoaxial Pedicle Screw, 40mm Lg. | In distribution | |
| ORO-8580R | Outer Diameter 8.5 mm | In distribution |
| Ø8.5mm Cannulated Polyaxial Reduction Pedicle Screw, 75mm Lg. | In distribution | |
| CP-008-34 | Length 125 mm | In distribution |
| CP-010-07 | In distribution | |
| CP-010-09 | In distribution | |
| ORO-7590R | Outer Diameter 7.5 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 75mm Lg. | In distribution | |
| ORO-6540R | Outer Diameter 6.5 mm | In distribution |
| Ø8.5mm Monoaxial Pedicle Screw, 40mm Lg. | In distribution | |
| ORO-5550R | Outer Diameter 5.5 mm | In distribution |
| ORO-6550R | Outer Diameter 6.5 mm | In distribution |
| CP-008-30 | Length 105 mm | In distribution |
| ORO-85105R | Outer Diameter 8.5 mm | In distribution |
| ORO-8530R | Outer Diameter 8.5 mm | In distribution |
| CP-010-08 | In distribution | |
| Ø7.5mm Monoaxial Pedicle Screw, 55mm Lg. | In distribution | |
| ORO-7585R | Outer Diameter 7.5 mm | In distribution |
| ORO-8540R | Outer Diameter 8.5 mm | In distribution |
| CP-008-36 | Length 135 mm | In distribution |
| ORO-5540R | Outer Diameter 5.5 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 100mm Lg. | In distribution | |
| ORO-8590R | Outer Diameter 8.5 mm | In distribution |
| CP-008-38 | Length 145 mm | In distribution |
| ORO-7550R | Outer Diameter 7.5 mm | In distribution |
| CP-010-10 | In distribution | |
| CP-010-11 | In distribution | |
| ORO-7560R | Outer Diameter 7.5 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Reduction Pedicle Screw, 80mm Lg. | In distribution | |
| ORO-8535R | Outer Diameter 8.5 mm | In distribution |
| Ø7.5mm Cannulated Polyaxial Pedicle Screw, 55mm Lg. | In distribution | |
| ORO-6535R | Outer Diameter 6.5 mm | In distribution |
| ORO-7570R | Outer Diameter 7.5 mm | In distribution |
| ORO-7580R | Outer Diameter 7.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ReLine | Nuvasive, Inc. | 2,998 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,568 |
| Creo | Globus Medical, Inc. | 1,765 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 1,755 |
| Ozark Cervical Plate System | VB Spine LLC | 1,460 |
| Sirion | Astura Medical | 1,246 |
| Apex Spine System | Spinecraft LLC | 1,187 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 986 |
| Astra Spine System | Spinecraft LLC | 970 |
| Zavation | Zavation | 966 |
| ACP | Nuvasive, Inc. | 918 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 877 |
Showing 12 of 855. All products under Appliance, Fixation, Spinal Intervertebral Body
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232256 | 2024-04-16 |
| K191584 | 2019-10-22 |
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.