Newport
Cannulated Reduction Polyaxial Screw, Diameter 7.5 x 110mm
13manufacturers in China registered for this device type
106catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K083089 |
| Record published | 2015-09-24 |
| Record revised | 2026-07-03 (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 |
| Distribution end date | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64-6535 | DIA6.5 x 35mm | In distribution |
| 60-0575 | 75mm | In distribution |
| 60-0390 | 90mm | In distribution |
| 61-7565 | DIA 7.5 x 65mm | In distribution |
| 64-6555 | DIA6.5 x 55mm | In distribution |
| 60-0370 | 70mm | In distribution |
| 64-6575 | DIA6.5 x 75mm | In distribution |
| 64-9580 | DIA9.5 x 80mm | In distribution |
| 60-0260 | In distribution | |
| 60-0340 | 40mm | In distribution |
| 60-0490 | 90mm | In distribution |
| 64-4740 | 4.75 x 40mm (4mm) | In distribution |
| 64-8575 | DIA8.5 x 75mm | In distribution |
| 64-9545 | 9.5 x 45mm (4mm) | In distribution |
| 60-0410 | 100mm | In distribution |
| 64-7530 | DIA7.5 x 30mm | In distribution |
| 63-5535 | Diameter 5.5 x 35mm | In distribution |
| 60-5540 | DIA 5.5 x 40mm | In distribution |
| 60-6555 | DIA 6.5 x 55mm | In distribution |
| 64-6500 | DIA6.5 x 100mm | In distribution |
| 63-5550 | Diameter 5.5 x 50mm | In distribution |
| 60-0480 | 80mm | In distribution |
| 60-0560 | 60mm | In distribution |
| 63-6545 | Diameter 6.5 x 45mm | In distribution |
| 64-8500 | DIA8.5 x 100mm | In distribution |
| 64-4750 | 4.75 x 50mm (4mm) | In distribution |
| 64-7575 | DIA7.5 x 75mm | In distribution |
| 64-7580 | DIA7.5 x 80mm | In distribution |
| 64-6505 | DIA6.5 x 105mm | In distribution |
| 60-0475 | 75mm | In distribution |
| 60-0545 | 45mm | In distribution |
| 60-0580 | 80mm | In distribution |
| 61-6555 | DIA 6.5 x 55mm | In distribution |
| 63-5525 | Diameter 5.5 x 25mm | In distribution |
| 60-0455 | 55mm | In distribution |
| 63-6550 | Diameter 6.5 x 50mm | In distribution |
| 60-0330 | 30mm | In distribution |
| 64-6540 | DIA6.5 x 40mm | In distribution |
| 60-0465 | 65mm | In distribution |
| 64-9560 | 9.5 x 60mm (4mm) | In distribution |
| 60-0311 | 110mm | In distribution |
| 64-7510 | DIA7.5 x 110mm | In distribution |
| 64-9535 | 9.5 x 35mm (4mm) | In distribution |
| 64-9555 | 9.5 x 55mm (4mm) | In distribution |
| 60-0375 | 75mm | In distribution |
| 64-6570 | DIA6.5 x 70mm | In distribution |
| 64-8560 | 8.5 x 60mm (4mm) | In distribution |
| 61-7555 | DIA 7.5 x 55mm | In distribution |
| 64-7565 | DIA7.5 x 65mm | In distribution |
| 61-6595 | DIA 6.5 x 95mm | Withdrawn |
| 63-6060 | Diameter 6.0 x 60mm | Withdrawn |
| 63-7055 | Diameter 7.0 x 55mm | Withdrawn |
| 63-7590 | Diameter 7.5 x 90mm | Withdrawn |
| 62-7025 | Diameter 7.0 x 25mm | Withdrawn |
| 63-6585 | Diameter 6.5 x 85mm | Withdrawn |
| 61-7070 | DIA 7.0 x 70mm | Withdrawn |
| 61-6050 | DIA 6.0 x 50mm | Withdrawn |
| 63-6040 | Diameter 6.0 x 40mm | Withdrawn |
| 61-7510 | DIA 7.5 x 110mm | Withdrawn |
| 62-6050 | Diameter 6.0 x 50mm | Withdrawn |
| 60-7535 | DIA 7.5 x 35mm | Withdrawn |
| 63-7045 | Diameter 7.0 x 45mm | Withdrawn |
| 60-7045 | DIA 7.0 x 45mm | Withdrawn |
| 60-0211 | 110mm | Withdrawn |
| 62-7530 | Diameter 7.5 x 30mm | Withdrawn |
| 62-7540 | Diameter 7.5 x 40mm | Withdrawn |
| 61-7000 | DIA 7.0 x 100mm | Withdrawn |
| 60-6035 | DIA 6.0 x 35mm | Withdrawn |
| 60-7025 | DIA 7.0 x 25mm | Withdrawn |
| 61-6530 | DIA 6.5 x 30mm | Withdrawn |
| 62-6555 | Diameter 6.5 x 55mm | Withdrawn |
| 62-6545 | Diameter 6.5 x 45mm | Withdrawn |
| 60-6525 | DIA 6.5 x 25mm | Withdrawn |
| 61-7055 | DIA 7.0 x 55mm | Withdrawn |
| 63-7065 | Diameter 7.0 x 65mm | Withdrawn |
| 63-6560 | Diameter 6.5 x 60mm | Withdrawn |
| 60-6025 | DIA 6.0 x 25mm | Withdrawn |
| 62-5545 | Diameter 5.5 x 45mm | Withdrawn |
| 62-6040 | Diameter 6.0 x 40mm | Withdrawn |
| 62-7550 | Diameter 7.5 x 50mm | Withdrawn |
| 61-6060 | DIA 6.0 x 60mm | Withdrawn |
| 62-6585 | Diameter 6.5 x 85mm | Withdrawn |
| 60-7525 | DIA 7.5 x 25mm | Withdrawn |
| 62-7565 | Diameter 7.5 x 65mm | Withdrawn |
| 62-6590 | Diameter 6.5 x 90mm | Withdrawn |
| 61-6575 | DIA 6.5 x 75mm | Withdrawn |
| 62-7510 | Diameter 7.5 x 110mm | Withdrawn |
| 60-5525 | DIA 5.5 x 25mm | Withdrawn |
| 60-0255 | 55mm | Withdrawn |
| 60-6050 | DIA 6.0 x 50mm | Withdrawn |
| 60-7040 | DIA 7.0 x 40mm | Withdrawn |
| 63-7050 | Diameter 7.0 x 50mm | Withdrawn |
| 61-6585 | DIA 6.5 x 85mm | Withdrawn |
| 60-5555 | DIA 5.5 x 55mm | Withdrawn |
| 60-0280 | 80mm | Withdrawn |
| 62-5550 | Diameter 5.5 x 50mm | Withdrawn |
| 63-7025 | Diameter 7.0 x 25mm | Withdrawn |
| 60-0290 | 90mm | Withdrawn |
| 61-7005 | DIA 7.0 x 105mm | Withdrawn |
| 63-7595 | Diameter 7.5 x 95mm | Withdrawn |
| 63-7505 | Diameter 7.5 x 105mm | Withdrawn |
| 63-5560 | Diameter 5.5 x 60mm | Withdrawn |
| 62-7560 | Diameter 7.5 x 60mm | Withdrawn |
| 63-6530 | Diameter 6.5 x 30mm | Withdrawn |
| 62-7500 | Diameter 7.5 x 100mm | Withdrawn |
| 62-7055 | Diameter 7.0 x 55mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Seaspine Orthopedics Corporation | 510(k) number | 2026-05-28 | Class II | Process change control | Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. | 796 units | |
| Integra Lifesciences Corporation | 510(k) number | 2014-06-27 | Class II | Under Investigation by firm | Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery. | 4 units | 2014-09-16 |
| Integra Lifesciences Corporation | 510(k) number | 2014-06-09 | Class II | Under Investigation by firm | Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. This could potentially result in the lordosis of the rod not alig | 94 units | 2014-11-06 |
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.