Apex Spine System
APEX Ti Cannulated Uniplanar Reduction Screw Dia.7.00, 50mm, Self-Tapping
13manufacturers in China registered for this device type
1,114catalogue 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 | Spinecraft LLC, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K110906 |
| Record published | 2014-09-24 |
| Record revised | 2025-07-14 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2024-09-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MR6-6280C | In distribution | |
| TC6-1500 | In distribution | |
| PR6-7725C | In distribution | |
| MR6-4765C-F | In distribution | |
| P6-5540 | In distribution | |
| P6-6280C | In distribution | |
| PR6-5575C | In distribution | |
| UR6-4760 | In distribution | |
| MF6-7755C | In distribution | |
| MF6-10030 | In distribution | |
| U6-4755C | In distribution | |
| MR6-70100-F | In distribution | |
| PR6-6250 | In distribution | |
| PF6-6285C | In distribution | |
| MR6-4725C-F | In distribution | |
| UR6-7050C-F | In distribution | |
| PR6-4750C | In distribution | |
| M6-77100C | In distribution | |
| P6-9260C | In distribution | |
| MR6-5540C | In distribution | |
| PR6-7760C | In distribution | |
| MR6-5585C-F | In distribution | |
| MF6-10070C | In distribution | |
| P60-222 | In distribution | |
| U6-6245 | In distribution | |
| M6-4730C | In distribution | |
| MR6-5570-F | In distribution | |
| PF6-7080 | In distribution | |
| PF6-8550C | In distribution | |
| U6-85100 | In distribution | |
| MR6-70100C | In distribution | |
| PR6-4735C | In distribution | |
| P6-10025C | In distribution | |
| M6-8560C | In distribution | |
| MF6-5555C | In distribution | |
| M6-6250 | In distribution | |
| PR6-5575C-F | In distribution | |
| MF6-8580 | In distribution | |
| PF6-8560C | In distribution | |
| UR6-5560 | In distribution | |
| M6-6265 | In distribution | |
| MR6-7070C-F | In distribution | |
| 6000-D5020-OC | In distribution | |
| PR6-4755C-F | In distribution | |
| MF6-7035C | In distribution | |
| PF6-6250 | In distribution | |
| P6-8570C | In distribution | |
| MF6-6235 | In distribution | |
| UR6-4745C | In distribution | |
| MR6-5585C | In distribution | |
| MR6-8530-F | In distribution | |
| UF6-7745C | In distribution | |
| PF6-6230C | In distribution | |
| P6-5575E | In distribution | |
| PR6-7725C-F | In distribution | |
| M6-6240C | In distribution | |
| U6-6250C | In distribution | |
| MR6-5585C | In distribution | |
| PF6-9270 | In distribution | |
| U6-5575C | In distribution | |
| MR6-7725 | In distribution | |
| PF6-7755 | In distribution | |
| PR6-7060 | In distribution | |
| UC6-2600 | In distribution | |
| PR6-70100C | In distribution | |
| M6-4725C | In distribution | |
| M6-9290C | In distribution | |
| P6-10050C | In distribution | |
| MR6-7045C | In distribution | |
| UR6-5540-F | In distribution | |
| PR6-7745C-F | In distribution | |
| M6-8545C | In distribution | |
| MF6-7045C | In distribution | |
| PF6-8535 | In distribution | |
| 6000-CR045 | In distribution | |
| MF6-5545 | In distribution | |
| M6-4725C | In distribution | |
| PF6-5535C | In distribution | |
| UR6-4740C-F | In distribution | |
| P6-6230C | In distribution | |
| M6-10030 | In distribution | |
| MF6-7740C | In distribution | |
| PF6-5565C | In distribution | |
| U6-7770 | In distribution | |
| UF6-6240C | In distribution | |
| PR6-4730C-F | In distribution | |
| PF6-9245 | In distribution | |
| UF6-7790 | In distribution | |
| M6-7740C | In distribution | |
| UF6-6285 | In distribution | |
| MR6-7040C-F | In distribution | |
| PF6-5580 | In distribution | |
| PR6-5585C-F | In distribution | |
| P6-7780 | In distribution | |
| MF6-7745C | In distribution | |
| MR6-5550C | In distribution | |
| MF6-7080C | In distribution | |
| MR6-7070 | In distribution | |
| MR6-7740-F | In distribution | |
| U6-4740C | In distribution | |
| UR6-4730C-F | In distribution | |
| PR6-4735C | In distribution | |
| PF6-4730 | In distribution | |
| 5500-300D | In distribution | |
| MF6-4730C | In distribution | |
| MR6-4750C | In distribution | |
| MR6-8540C | In distribution | |
| MF6-9255C | In distribution | |
| MR6-8535-F | In distribution | |
| MF6-4765C | In distribution | |
| MR6-7745C | In distribution | |
| PR6-5555-F | In distribution | |
| MR6-7730C-F | In distribution | |
| PF6-8530C | In distribution | |
| U6-7735C | In distribution | |
| M6-4740 | In distribution | |
| SS6-T20F | In distribution | |
| MR6-4775C | In distribution | |
| UR6-5565C | In distribution | |
| PR6-5525C | In distribution | |
| PR6-8555C-F | In distribution | |
| PF6-4725C | In distribution | |
| PF6-5575C | In distribution | |
| MF6-5550C | In distribution | |
| UR6-7040 | In distribution | |
| MR6-6270C-F | In distribution | |
| UR6-5540C-F | In distribution | |
| M6-8525C | In distribution | |
| PR6-7790C-F | In distribution | |
| PR6-6235 | In distribution | |
| TX6-2428 | In distribution | |
| 6000-060L | In distribution | |
| MR6-7055C | In distribution | |
| PF6-4755C | In distribution | |
| M6-4735C | In distribution | |
| P6-7770C | In distribution | |
| UR6-4785 | In distribution | |
| MR6-4770C-F | In distribution | |
| PR6-5525C-F | In distribution | |
| MF6-5530 | In distribution | |
| UF6-4785C | In distribution | |
| U6-4725C | In distribution | |
| UR6-6240-F | In distribution | |
| PR6-5580C | In distribution | |
| UR6-6230C | In distribution | |
| P6-8590 | In distribution | |
| MF6-7755 | In distribution | |
| M6-9225C | In distribution | |
| P6-6230E | In distribution | |
| MF6-6265C | In distribution | |
| UF6-5535 | In distribution | |
| MR6-5560-F | In distribution | |
| PF6-5555 | In distribution | |
| MF6-10050C | In distribution | |
| PR6-7745 | In distribution | |
| UR6-6270-F | In distribution | |
| UF6-8590 | In distribution | |
| 6000-T8070 | In distribution | |
| PR6-6250C | In distribution | |
| UF6-4770 | In distribution | |
| PF6-6285E | In distribution | |
| PR6-4780C | In distribution | |
| 5500-D5020-OC | In distribution | |
| P6-8540C | In distribution | |
| MR6-5560C | In distribution | |
| 5500-CR070 | In distribution | |
| MR6-6230-F | In distribution | |
| M6-7735C | In distribution | |
| MR6-6275C | In distribution | |
| MR6-7755 | In distribution | |
| PF6-6255C | In distribution | |
| M6-9235C | In distribution | |
| M6-6255C | In distribution | |
| P6-7040C | In distribution | |
| BX6 | In distribution | |
| UR6-4765 | In distribution | |
| 5500-110ML | In distribution | |
| 5500-035ML | In distribution | |
| UR6-5550C | In distribution | |
| U6-5555 | In distribution | |
| UF6-85100C | In distribution | |
| PR6-6240C | In distribution | |
| U6-6285C | In distribution | |
| PF6-8580 | In distribution | |
| P6-7050 | In distribution | |
| MR6-5570C | In distribution | |
| M6-7080C | In distribution | |
| PR6-7055 | In distribution | |
| MR6-6280C-F | In distribution | |
| 5500-CR600D | In distribution | |
| MF6-5525C | In distribution | |
| P6-4755E | In distribution | |
| M6-7030 | In distribution | |
| MF6-4760 | In distribution | |
| M6-7790 | In distribution | |
| M6-10070 | In distribution | |
| M6-9255C | In distribution | |
| UF6-4740C | In distribution | |
| PR6-6280-F | In distribution | |
| MR6-7740 | In distribution | |
| UR6-4735 | In distribution | |
| PF6-7790C | In distribution | |
| 6000-040ML | In distribution | |
| MF6-6240 | In distribution | |
| 5500-090L | In distribution | |
| P6-6240 | In distribution | |
| MR6-6245-F | In distribution | |
| MF6-7730C | In distribution | |
| MF6-10055 | In distribution | |
| PF6-10030 | In distribution | |
| M6-8550C | In distribution | |
| PF6-9290 | In distribution | |
| MR6-7780 | In distribution | |
| UF6-8560 | In distribution | |
| PF6-7040C | In distribution | |
| M6-6245 | In distribution | |
| UR6-5575 | In distribution | |
| UF6-6275C | In distribution | |
| PR6-4735 | In distribution | |
| PF6-7735 | In distribution | |
| M6-7055 | In distribution | |
| 5500-050ML | In distribution | |
| UR6-5525-F | In distribution | |
| M6-7040C | In distribution | |
| UR6-4770C-F | In distribution | |
| PF6-6225C | In distribution | |
| MF6-9250C | In distribution | |
| PF6-9280 | In distribution | |
| PF6-7035 | In distribution | |
| MR6-8525 | In distribution | |
| F6-1837 | In distribution | |
| P6-5535 | In distribution | |
| PF6-7055C | In distribution | |
| 6000-030 | In distribution | |
| MF6-6245C | In distribution | |
| PR6-8590 | In distribution | |
| M6-7740C | In distribution | |
| 6000-110ML | In distribution | |
| MR6-7055C | In distribution | |
| P6-8555C | In distribution | |
| MF6-7090C | In distribution | |
| PF6-4750C | In distribution | |
| P6-10030 | In distribution | |
| M6-5575C | In distribution | |
| UR6-4765-F | In distribution | |
| UR6-4780 | In distribution | |
| MR6-8555-F | In distribution | |
| U6-6275C | In distribution | |
| PR6-4770-F | In distribution | |
| P6-5570C | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Astra Spine System | Spinecraft LLC | 786 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.