NorthStar
Contoured CoCr OCC Rod, 3.5mm x 170mm x 70 Deg
11manufacturers in China registered for this device type
230catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K193615 |
| Record published | 2020-06-15 |
| Record revised | 2025-10-24 (version 5) |
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 |
|---|---|---|
| PC1-016000 | In distribution | |
| PC1-004524 | In distribution | |
| PC1-313542 | In distribution | |
| PC1-304040 | In distribution | |
| PC1-010001 | In distribution | |
| PC1-513575 | In distribution | |
| PC1-513570 | In distribution | |
| PC1-004520 | In distribution | |
| PC1-513177 | In distribution | |
| PC1-504001 | In distribution | |
| PC1-504060 | In distribution | |
| PC1-504090 | In distribution | |
| PC1-313538 | In distribution | |
| PC1-704012 | In distribution | |
| PC1-514080 | In distribution | |
| PC1-314048 | In distribution | |
| PC1-014500 | In distribution | |
| PC1-314514 | In distribution | |
| PC1-304516 | In distribution | |
| PC1-104524 | In distribution | |
| PC1-003512 | In distribution | |
| PC1-104522 | In distribution | |
| PC1-003538 | In distribution | |
| PC1-003532 | In distribution | |
| PC1-104540 | In distribution | |
| PC1-004534 | In distribution | |
| PC1-104550 | In distribution | |
| PC1-303516 | In distribution | |
| PC1-204024 | In distribution | |
| PC1-004510 | In distribution | |
| PC1-304540 | In distribution | |
| PC1-513535 | In distribution | |
| PC1-523560 | In distribution | |
| PC1-704507 | In distribution | |
| PC1-304550 | In distribution | |
| PC1-513540 | In distribution | |
| PC1-004038 | In distribution | |
| PC1-304028 | In distribution | |
| PC1-203550 | In distribution | |
| PC1-303530 | In distribution | |
| PC1-034500 | In distribution | |
| PC1-514112 | In distribution | |
| PC1-513555 | In distribution | |
| PC1-004512 | In distribution | |
| PC1-314526 | In distribution | |
| PC1-714513 | In distribution | |
| PC1-504035 | In distribution | |
| PC1-503500 | In distribution | |
| PC1-504003 | In distribution | |
| PC1-315516 | In distribution | |
| PC1-105530 | In distribution | |
| PC1-303508 | In distribution | |
| PC1-105522 | In distribution | |
| PC1-304536 | In distribution | |
| PC1-315514 | In distribution | |
| PC1-714516 | In distribution | |
| PC1-704515 | In distribution | |
| PC1-304012 | In distribution | |
| PC1-514111 | In distribution | |
| PC1-014004 | In distribution | |
| PC1-303512 | In distribution | |
| PC1-514065 | In distribution | |
| PC1-314040 | In distribution | |
| PC1-014001 | In distribution | |
| PC1-013504 | In distribution | |
| PC1-503595 | In distribution | |
| PC1-534060 | In distribution | |
| PC1-304544 | In distribution | |
| PC1-514075 | In distribution | |
| PC1-504095 | In distribution | |
| PC1-313534 | In distribution | |
| PC1-104546 | In distribution | |
| PC1-204044 | In distribution | |
| PC1-503502 | In distribution | |
| PC1-504002 | In distribution | |
| PC3-000019 | In distribution | |
| PC1-304046 | In distribution | |
| PC2-300003 | In distribution | |
| PC1-104538 | In distribution | |
| PC1-503503 | In distribution | |
| PC1-004516 | In distribution | |
| PC1-303518 | In distribution | |
| PC1-314524 | In distribution | |
| PC1-203528 | In distribution | |
| PC1-714500 | In distribution | |
| PC1-143540 | In distribution | |
| PC1-303546 | In distribution | |
| PC1-303536 | In distribution | |
| PC1-315542 | In distribution | |
| PC1-043560 | In distribution | |
| PC1-714511 | In distribution | |
| PC1-104528 | In distribution | |
| PC1-514012 | In distribution | |
| PC1-704007 | In distribution | |
| PC1-313536 | In distribution | |
| PC1-003544 | In distribution | |
| PC1-514040 | In distribution | |
| PC1-105548 | In distribution | |
| PC1-104530 | In distribution | |
| PC1-504070 | In distribution | |
| PC1-714013 | In distribution | |
| PC1-714008 | In distribution | |
| PC1-004046 | In distribution | |
| PC1-514177 | In distribution | |
| PC1-314036 | In distribution | |
| PC2-200010 | In distribution | |
| PC3-000018 | In distribution | |
| PC1-400000 | In distribution | |
| PC1-704512 | In distribution | |
| PC1-714509 | In distribution | |
| PC1-003526 | In distribution | |
| PC1-313528 | In distribution | |
| PC1-704508 | In distribution | |
| PC1-304008 | In distribution | |
| PC1-503585 | In distribution | |
| PC1-304518 | In distribution | |
| PC1-514085 | In distribution | |
| PC1-303520 | In distribution | |
| PC1-714012 | In distribution | |
| PC2-200008 | In distribution | |
| PC1-704009 | In distribution | |
| PC1-313520 | In distribution | |
| PC1-004040 | In distribution | |
| PC1-026000 | In distribution | |
| PC1-014011 | In distribution | |
| PC1-203548 | In distribution | |
| PC1-304038 | In distribution | |
| PC1-534055 | In distribution | |
| PC1-314034 | In distribution | |
| PC1-304042 | In distribution | |
| PC1-314044 | In distribution | |
| PC1-700003 | In distribution | |
| PC1-503580 | In distribution | |
| PC1-514070 | In distribution | |
| PC1-303550 | In distribution | |
| PC1-504085 | In distribution | |
| PC1-503530 | In distribution | |
| PC1-523555 | In distribution | |
| PC1-204034 | In distribution | |
| PC1-314520 | In distribution | |
| PC1-304030 | In distribution | |
| PC2-200000 | In distribution | |
| PC1-104510 | In distribution | |
| PC1-004024 | In distribution | |
| PC1-304510 | In distribution | |
| PC1-303514 | In distribution | |
| PC1-024500 | In distribution | |
| PC1-503555 | In distribution | |
| PC1-004540 | In distribution | |
| PC1-513545 | In distribution | |
| PC1-315522 | In distribution | |
| PC1-303526 | In distribution | |
| PC1-314024 | In distribution | |
| PC1-123560 | In distribution | |
| PC1-513504 | In distribution | |
| PC1-105528 | In distribution | |
| PC1-304542 | In distribution | |
| PC1-700004 | In distribution | |
| PC1-003540 | In distribution | |
| PC1-304036 | In distribution | |
| PC1-313550 | In distribution | |
| PC1-104516 | In distribution | |
| PC1-304026 | In distribution | |
| PC1-303524 | In distribution | |
| PC1-004544 | In distribution | |
| PC1-003518 | In distribution | |
| PC1-315526 | In distribution | |
| PC1-314540 | In distribution | |
| PC1-504177 | In distribution | |
| PC1-204046 | In distribution | |
| PC1-203530 | In distribution | |
| PC1-014013 | In distribution | |
| PC1-104518 | In distribution | |
| PC1-304024 | In distribution | |
| PC1-004530 | In distribution | |
| PC1-313548 | In distribution | |
| PC1-104548 | In distribution | |
| PC1-714014 | In distribution | |
| PC1-204020 | In distribution | |
| PC1-304530 | In distribution | |
| PC1-714515 | In distribution | |
| PC1-304538 | In distribution | |
| PC1-204032 | In distribution | |
| PC1-104542 | In distribution | |
| PC1-304032 | In distribution | |
| PC1-503176 | In distribution | |
| PC1-514095 | In distribution | |
| PC1-203524 | In distribution | |
| PC1-004522 | In distribution | |
| PC1-514060 | In distribution | |
| PC1-004012 | In distribution | |
| PC1-704513 | In distribution | |
| PC1-004550 | In distribution | |
| PC1-203534 | In distribution | |
| PC1-513530 | In distribution | |
| PC1-014002 | In distribution | |
| PC1-514045 | In distribution | |
| PC1-314032 | In distribution | |
| PC1-004528 | In distribution | |
| PC1-314534 | In distribution | |
| PC1-004514 | In distribution | |
| PC1-303522 | In distribution | |
| PC1-524055 | In distribution | |
| PC1-104512 | In distribution | |
| PC1-104520 | In distribution | |
| PC1-204050 | In distribution | |
| PC1-504065 | In distribution | |
| PC1-704510 | In distribution | |
| PC1-314522 | In distribution | |
| PC1-023560 | In distribution | |
| PC1-503565 | In distribution | |
| PC1-704011 | In distribution | |
| PC3-510002 | In distribution | |
| PC1-003528 | In distribution | |
| PC1-203520 | In distribution | |
| PC1-204028 | In distribution | |
| PC1-315544 | In distribution | |
| PC1-513176 | In distribution | |
| PC1-204048 | In distribution | |
| PC1-714508 | In distribution | |
| PC1-303540 | In distribution | |
| PC1-204042 | In distribution | |
| PC1-104544 | In distribution | |
| PC1-304546 | In distribution | |
| PC1-714016 | In distribution | |
| PC1-704010 | In distribution | |
| PC1-014003 | In distribution | |
| PC1-514101 | In distribution | |
| PC1-315550 | In distribution | |
| PC1-105550 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
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.