Apex-DL Spine System
APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 90mm, Self-Tapping
13manufacturers in China registered for this device type
792catalogue 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 |
| Record published | 2015-08-18 |
| Record revised | 2024-09-11 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DUR6-70100C | In distribution | |
| DUF6-6250C | In distribution | |
| DUR6-7050C | In distribution | |
| DMR6-7070 | In distribution | |
| DM6-8555C | In distribution | |
| DPF6-7745C | In distribution | |
| DMF6-4745 | In distribution | |
| DM6-5585C | In distribution | |
| DM6-6255 | In distribution | |
| DPR6-7045-F | In distribution | |
| DUR6-7090C-F | In distribution | |
| DU6-7790C | In distribution | |
| DMF6-5530C | In distribution | |
| DUR6-6225-F | In distribution | |
| DMF6-9250C | In distribution | |
| DMF6-10045C | In distribution | |
| DMR6-6235-F | In distribution | |
| DPF6-10060 | In distribution | |
| DUR6-6230C | In distribution | |
| DP6-7045C | In distribution | |
| DMF6-5575 | In distribution | |
| DP6-10040C | In distribution | |
| DMR6-6285C-F | In distribution | |
| DUF6-5535 | In distribution | |
| DPR6-8590 | In distribution | |
| DMR6-5570C-F | In distribution | |
| DMR6-7050-F | In distribution | |
| DM6-7755C | In distribution | |
| DMR6-7070-F | In distribution | |
| DM6-8590 | In distribution | |
| DPF6-5570C | In distribution | |
| DP6-9255 | In distribution | |
| DMR6-4775C | In distribution | |
| DUF6-7025 | In distribution | |
| DMF6-8560 | In distribution | |
| DU6-70100C | In distribution | |
| DU6-8570 | In distribution | |
| DMF6-6265 | In distribution | |
| DP6-9235 | In distribution | |
| DUF6-4785 | In distribution | |
| DPR6-7725-F | In distribution | |
| DMR6-4755-F | In distribution | |
| DP6-9240 | In distribution | |
| DMR6-6255C | In distribution | |
| DPF6-6270 | In distribution | |
| DPR6-7070 | In distribution | |
| DM6-85100 | In distribution | |
| DPF6-5550C | In distribution | |
| DUR6-6275 | In distribution | |
| DUR6-5575C | In distribution | |
| DMR6-6245C | In distribution | |
| DMR6-4745C-F | In distribution | |
| DP6-9225 | In distribution | |
| DPR6-5535C-F | In distribution | |
| DMF6-5550 | In distribution | |
| DMR6-7770-F | In distribution | |
| DMF6-5545 | In distribution | |
| DP6-10080 | In distribution | |
| DUR6-6240C-F | In distribution | |
| DMR6-7030C | In distribution | |
| DPR6-7060 | In distribution | |
| DMF6-9235C | In distribution | |
| DUF6-6280 | In distribution | |
| DUF6-5565C | In distribution | |
| DPR6-5555-F | In distribution | |
| DM6-5535C | In distribution | |
| DMF6-6285C | In distribution | |
| DPF6-7060 | In distribution | |
| DM6-10055 | In distribution | |
| DP6-5550 | In distribution | |
| DPF6-5570 | In distribution | |
| DP6-10035 | In distribution | |
| DPR6-8530C-F | In distribution | |
| DU6-4745C | In distribution | |
| DMF6-6235C | In distribution | |
| DPR6-7730C-F | In distribution | |
| DPR6-6285-F | In distribution | |
| DUR6-5575 | In distribution | |
| DPR6-8535 | In distribution | |
| DUR6-6230C-F | In distribution | |
| DPF6-6280 | In distribution | |
| DUR6-7090-F | In distribution | |
| DUF6-5580C | In distribution | |
| DUF6-4785C | In distribution | |
| DPR6-5585 | In distribution | |
| DPF6-7760C | In distribution | |
| DPR6-5550C | In distribution | |
| DMR6-4745 | In distribution | |
| DUF6-5570C | In distribution | |
| DPF6-8525-XL | In distribution | |
| DPF6-7025C | In distribution | |
| DMR6-6285C | In distribution | |
| DUR6-5540C-F | In distribution | |
| DP6-8570C | In distribution | |
| DMR6-8570C-F | In distribution | |
| DMF6-10090 | In distribution | |
| DMF6-7750 | In distribution | |
| DP6-92100 | In distribution | |
| DU6-5545 | In distribution | |
| DMR6-8590C | In distribution | |
| DMR6-8530 | In distribution | |
| DMR6-6255 | In distribution | |
| DM6-6285C | In distribution | |
| DM6-10025C | In distribution | |
| DM6-6230C | In distribution | |
| DP6-5540C | In distribution | |
| DUF6-5560 | In distribution | |
| DUR6-5565C | In distribution | |
| DUR6-7035 | In distribution | |
| DPR6-5565C-F | In distribution | |
| DUF6-7090 | In distribution | |
| DUF6-7790 | In distribution | |
| DPR6-5535 | In distribution | |
| DMF6-70100 | In distribution | |
| DM6-10030 | In distribution | |
| DPF6-6235C | In distribution | |
| DMF6-5580 | In distribution | |
| DPR6-8580-F | In distribution | |
| DMR6-5550C-F | In distribution | |
| DP6-6265 | In distribution | |
| DUR6-7080-F | In distribution | |
| DMR6-7035C | In distribution | |
| DUF6-6240C | In distribution | |
| DMR6-7740 | In distribution | |
| DP6-4740 | In distribution | |
| DP6-5530 | In distribution | |
| DMF6-8535C | In distribution | |
| DPR6-7030 | In distribution | |
| DPF6-6225 | In distribution | |
| DP6-9255C | In distribution | |
| DM6-5555C | In distribution | |
| DM6-9290 | In distribution | |
| DMR6-6280 | In distribution | |
| DMR6-7790-F | In distribution | |
| DMR6-8550C-F | In distribution | |
| DMF6-8570C | In distribution | |
| DPR6-4785C | In distribution | |
| DU6-5540 | In distribution | |
| DPR6-7040 | In distribution | |
| DPR6-8525-F | In distribution | |
| DP6-9230C | In distribution | |
| DUR6-5525C | In distribution | |
| DUR6-6245-F | In distribution | |
| DM6-10090 | In distribution | |
| DM6-4730 | In distribution | |
| DMR6-4770C | In distribution | |
| DMR6-6285 | In distribution | |
| DUR6-4725C | In distribution | |
| DMF6-6270 | In distribution | |
| DP6-7790 | In distribution | |
| DP6-10045C | In distribution | |
| DMF6-7780C | In distribution | |
| DPF6-5530 | In distribution | |
| DUF6-70100C | In distribution | |
| DUR6-4780C-F | In distribution | |
| DPF6-6270C | In distribution | |
| DMR6-7030 | In distribution | |
| DMF6-9240 | In distribution | |
| DUF6-6280C | In distribution | |
| DPR6-77100 | In distribution | |
| DUF6-77100 | In distribution | |
| DUF6-6245 | In distribution | |
| DMF6-9255 | In distribution | |
| DPR6-4740 | In distribution | |
| DPR6-7750 | In distribution | |
| DPR6-8535C | In distribution | |
| DPF6-6265 | In distribution | |
| DP6-7035C | In distribution | |
| DM6-9280C | In distribution | |
| DPR6-7740C-F | In distribution | |
| DUR6-5570C-F | In distribution | |
| DMF6-7760C | In distribution | |
| DUF6-8590 | In distribution | |
| DPR6-7050-F | In distribution | |
| DMR6-8570 | In distribution | |
| DMR6-6260 | In distribution | |
| DM6-4750C | In distribution | |
| DPF6-8570-XL | In distribution | |
| DUR6-4750C-F | In distribution | |
| DMF6-6245C | In distribution | |
| DU6-7770C | In distribution | |
| DMF6-7755C | In distribution | |
| DMF6-5540C | In distribution | |
| DPR6-4765C-F | In distribution | |
| DU6-5580C | In distribution | |
| DPF6-6260 | In distribution | |
| DU6-6235 | In distribution | |
| DMR6-4745-F | In distribution | |
| DM6-4765C | In distribution | |
| DUR6-6235C | In distribution | |
| DMF6-7790C | In distribution | |
| DMR6-5535-F | In distribution | |
| DPR6-7030C-F | In distribution | |
| DMF6-9290C | In distribution | |
| DMR6-4725C-F | In distribution | |
| DP6-6250 | In distribution | |
| DMR6-4765-F | In distribution | |
| DMR6-5550-F | In distribution | |
| DMR6-7055 | In distribution | |
| DMR6-5545C | In distribution | |
| DU6-6255C | In distribution | |
| DUF6-4740 | In distribution | |
| DMR6-7025C-F | In distribution | |
| DPF6-9290 | In distribution | |
| DMF6-4755C | In distribution | |
| DUF6-5580 | In distribution | |
| DPF6-85100-XL | In distribution | |
| DPF6-10040C | In distribution | |
| DMR6-5530C-F | In distribution | |
| DM6-10070 | In distribution | |
| DPR6-4745-F | In distribution | |
| DPR6-4770C | In distribution | |
| DP6-9270C | In distribution | |
| DU6-7060 | In distribution | |
| DPR6-8590C | In distribution | |
| DUR6-5535 | In distribution | |
| DP6-10045 | In distribution | |
| DPR6-8530C | In distribution | |
| DUF6-8535 | In distribution | |
| DM6-8555 | In distribution | |
| DMF6-7045 | In distribution | |
| DUR6-6240-F | In distribution | |
| DP6-7070 | In distribution | |
| DMF6-9240C | In distribution | |
| DPR6-4760 | In distribution | |
| DPR6-7735 | In distribution | |
| DP6-10050 | In distribution | |
| DPF6-6255C | In distribution | |
| DUR6-4770C | In distribution | |
| DPF6-5530C | In distribution | |
| DUF6-7080C | In distribution | |
| DUF6-7090C | In distribution | |
| DMR6-5555C | In distribution | |
| DPR6-5580-F | In distribution | |
| DM6-6260C | In distribution | |
| DUR6-5530-F | In distribution | |
| DP6-7760C | In distribution | |
| DUR6-7035-F | In distribution | |
| DP6-4745C | In distribution | |
| DMF6-7035 | In distribution | |
| DMR6-7030-F | In distribution | |
| DUF6-6285C | In distribution | |
| DMR6-7745 | In distribution | |
| DUF6-6235 | In distribution | |
| DM6-8550 | In distribution | |
| DMR6-4775-F | In distribution | |
| DPR6-8580 | In distribution | |
| DMR6-7090 | In distribution | |
| DM6-9235C | In distribution | |
| DU6-4740C | 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 |
| 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 |
| 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.