Apex-DL Spine System
APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 100mm, Self-Tapping
13manufacturers in China registered for this device type
735catalogue numbers in this listing
1510(k) clearance
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, Spondylolisthesis Spinal Fixation
Record
| Listed by | Spinecraft LLC, United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2019-03-27 |
| 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 |
|---|---|---|
| DM6-5525 | In distribution | |
| DM6-7745C | In distribution | |
| DMR6-7060C-F | In distribution | |
| DU6-6260C | In distribution | |
| DP6-5565 | In distribution | |
| DPF6-6275 | In distribution | |
| DMR6-5530-F | In distribution | |
| DP6-4730 | In distribution | |
| DMF6-4775C | In distribution | |
| DUF6-7770 | In distribution | |
| DP6-4740C | In distribution | |
| DU6-4755C | In distribution | |
| DMR6-7745-F | In distribution | |
| DUF6-7060 | In distribution | |
| DP6-6270C | In distribution | |
| DPR6-70100 | In distribution | |
| DM6-10045 | In distribution | |
| DUR6-4770C-F | In distribution | |
| DUF6-8545 | In distribution | |
| DPF6-4730C | In distribution | |
| DUR6-4760-F | In distribution | |
| DMR6-4770C-F | In distribution | |
| DUF6-7725C | In distribution | |
| DMR6-5585C-F | In distribution | |
| DMR6-6225C | In distribution | |
| DUR6-7060C-F | In distribution | |
| DM6-5530 | In distribution | |
| DPR6-6255C | In distribution | |
| DM6-5530C | In distribution | |
| DPR6-4780C | In distribution | |
| DM6-7780 | In distribution | |
| DMF6-7725 | In distribution | |
| DMF6-8545C | In distribution | |
| DPR6-5575C-F | In distribution | |
| DPR6-7055-F | In distribution | |
| DP6-7730 | In distribution | |
| DPF6-7740C | In distribution | |
| DPF6-4775 | In distribution | |
| DUF6-5555C | In distribution | |
| DMR6-7755C | In distribution | |
| DPR6-6245C | In distribution | |
| DMF6-4730C | In distribution | |
| DUR6-4735 | In distribution | |
| DP6-8535 | In distribution | |
| DUR6-70100 | In distribution | |
| DPF6-8550C | In distribution | |
| DM6-10025 | In distribution | |
| DPR6-8555C | In distribution | |
| DPR6-4775 | In distribution | |
| DPR6-7040C | In distribution | |
| DMR6-6280C-F | In distribution | |
| DP6-8560 | In distribution | |
| DU6-6275C | In distribution | |
| DP6-5535C | In distribution | |
| DPF6-10060C | In distribution | |
| DMF6-100100C | In distribution | |
| DUF6-7760 | In distribution | |
| DM6-100100C | In distribution | |
| DM6-6275 | In distribution | |
| DUF6-6230 | In distribution | |
| DP6-8560C | In distribution | |
| DU6-4780 | In distribution | |
| DUR6-7045C-F | In distribution | |
| DPR6-7045C-F | In distribution | |
| DP6-6240 | In distribution | |
| DM6-9250C | In distribution | |
| DP6-4725 | In distribution | |
| DUF6-6250 | In distribution | |
| DM6-7025C | In distribution | |
| DPR6-77100C | In distribution | |
| DUR6-5530 | In distribution | |
| DUF6-7770C | In distribution | |
| DPR6-7055C-F | In distribution | |
| DMR6-7055C | In distribution | |
| DUR6-4755 | In distribution | |
| DPF6-4735 | In distribution | |
| DUF6-6255 | In distribution | |
| DMR6-8560 | In distribution | |
| DUR6-6250C | In distribution | |
| DU6-6265C | In distribution | |
| DPF6-7730C | In distribution | |
| DMR6-5540C | In distribution | |
| DM6-92100C | In distribution | |
| DPR6-5545C-F | In distribution | |
| DMF6-10030 | In distribution | |
| DUR6-7040C | In distribution | |
| DPR6-7035C-F | In distribution | |
| DUF6-6285 | In distribution | |
| DPR6-4730C | In distribution | |
| DPR6-7725 | In distribution | |
| DM6-7755 | In distribution | |
| DUR6-5550C-F | In distribution | |
| DUR6-70100C-F | In distribution | |
| DPR6-4755C | In distribution | |
| DP6-5585C | In distribution | |
| DPR6-5555C-F | In distribution | |
| DPR6-6225C | In distribution | |
| DPR6-4750-F | In distribution | |
| DPF6-7030 | In distribution | |
| DPR6-4745C-F | In distribution | |
| DU6-6270C | In distribution | |
| DPR6-70100-F | In distribution | |
| DPR6-8580C | In distribution | |
| DU6-5555C | In distribution | |
| DPR6-5550 | In distribution | |
| DPF6-6250 | In distribution | |
| DP6-9270 | In distribution | |
| DU6-8540 | In distribution | |
| DM6-7035 | In distribution | |
| DUR6-4760C-F | In distribution | |
| DMR6-4750-F | In distribution | |
| DUR6-4755C-F | In distribution | |
| DMF6-10025 | In distribution | |
| DMR6-7730C-F | In distribution | |
| DMR6-7025-F | In distribution | |
| DP6-10080C | In distribution | |
| DM6-6245C | In distribution | |
| DPF6-8545C | In distribution | |
| DUF6-4765 | In distribution | |
| DM6-7030C | In distribution | |
| DUR6-4740 | In distribution | |
| DM6-7750C | In distribution | |
| DPR6-6270C-F | In distribution | |
| DPF6-6240 | In distribution | |
| DMR6-5565C | In distribution | |
| DPR6-7070C | In distribution | |
| DPR6-6275 | In distribution | |
| DPR6-4765-F | In distribution | |
| DM6-9245C | In distribution | |
| DP6-4760 | In distribution | |
| DMF6-4760C | In distribution | |
| DPR6-77100C-F | In distribution | |
| DMF6-6240 | In distribution | |
| DP6-9280C | In distribution | |
| DMR6-4760C-F | In distribution | |
| DM6-7760 | In distribution | |
| DUF6-6225C | In distribution | |
| DU6-6230C | In distribution | |
| DM6-6225 | In distribution | |
| DPR6-8530-F | In distribution | |
| DUF6-8525C | In distribution | |
| DPF6-8590 | In distribution | |
| DP6-5560C | In distribution | |
| DU6-5540C | In distribution | |
| DPF6-10080 | In distribution | |
| DP6-6280 | In distribution | |
| DMR6-7080C | In distribution | |
| DU6-7740C | In distribution | |
| DPF6-5535 | In distribution | |
| DP6-5580 | In distribution | |
| DU6-7745C | In distribution | |
| DPR6-7770 | In distribution | |
| DPF6-8570 | In distribution | |
| DM6-7735C | In distribution | |
| DMF6-4765 | In distribution | |
| DUR6-4750-F | In distribution | |
| DUR6-6275-F | In distribution | |
| DPF6-5585C | In distribution | |
| DM6-6235 | In distribution | |
| DPR6-7080C-F | In distribution | |
| DPR6-85100-F | In distribution | |
| DUR6-7025 | In distribution | |
| DUR6-5580C | In distribution | |
| DM6-5570C | In distribution | |
| DPR6-6240C | In distribution | |
| DUR6-4745C | In distribution | |
| DMR6-7740C | In distribution | |
| DMR6-7780 | In distribution | |
| DPF6-4755 | In distribution | |
| DPR6-7050C | In distribution | |
| DMF6-6280C | In distribution | |
| DUR6-4745 | In distribution | |
| DM6-9270 | In distribution | |
| DMF6-6280 | In distribution | |
| DP6-4735 | In distribution | |
| DPR6-7730 | In distribution | |
| DMF6-7025C | In distribution | |
| DP6-5545C | In distribution | |
| DMF6-5570 | In distribution | |
| DMR6-8580C-F | In distribution | |
| DMF6-4785C | In distribution | |
| DM6-7040 | In distribution | |
| DMR6-7035 | In distribution | |
| DU6-6245C | In distribution | |
| DPR6-7790-F | In distribution | |
| DPR6-7730-F | In distribution | |
| DPR6-7090 | In distribution | |
| DMR6-5565C-F | In distribution | |
| DM6-9290C | In distribution | |
| DUR6-7050 | In distribution | |
| DPR6-6275C | In distribution | |
| DMR6-7050C-F | In distribution | |
| DMR6-5540-F | In distribution | |
| DU6-7780C | In distribution | |
| DMR6-8525 | In distribution | |
| DPR6-6260C-F | In distribution | |
| DM6-10030C | In distribution | |
| DUR6-7080C-F | In distribution | |
| DP6-10060 | In distribution | |
| DMR6-6270C-F | In distribution | |
| DMR6-4765 | In distribution | |
| DPF6-70100C | In distribution | |
| DPF6-85100 | In distribution | |
| DMF6-6235 | In distribution | |
| DUF6-8525 | In distribution | |
| DMF6-6225 | In distribution | |
| DP6-70100 | In distribution | |
| DU6-7040 | In distribution | |
| DPR6-6255C-F | In distribution | |
| DUF6-7780 | In distribution | |
| DUF6-5545 | In distribution | |
| DUF6-6260C | In distribution | |
| DUF6-4725C | In distribution | |
| DPR6-6265C-F | In distribution | |
| DMF6-7745C | In distribution | |
| DMR6-6255-F | In distribution | |
| DP6-6275 | In distribution | |
| DPF6-4750C | In distribution | |
| DMF6-5545C | In distribution | |
| DUR6-6265 | In distribution | |
| DUR6-6255C | In distribution | |
| DMF6-10055 | In distribution | |
| DUF6-8580 | In distribution | |
| DUF6-5525 | In distribution | |
| DPF6-9280 | In distribution | |
| DMR6-7760C | In distribution | |
| DP6-7725 | In distribution | |
| DPF6-4785C | In distribution | |
| DPF6-8535C | In distribution | |
| DPR6-7740C | In distribution | |
| DP6-6255 | In distribution | |
| DU6-5575C | In distribution | |
| DM6-8560C | In distribution | |
| DMR6-8545C-F | In distribution | |
| DUF6-7755 | In distribution | |
| DMR6-4780 | In distribution | |
| DU6-5585 | In distribution | |
| DUR6-7035C | In distribution | |
| DP6-6245 | In distribution | |
| DP6-4750C | In distribution | |
| DUF6-8530C | In distribution | |
| DMF6-10070C | In distribution | |
| DPR6-7790 | In distribution | |
| DPF6-7035 | In distribution | |
| DUF6-7045C | In distribution | |
| DPR6-8550C-F | In distribution | |
| DMR6-5560-F | In distribution | |
| DMR6-8555-F | In distribution | |
| DP6-4765C | In distribution | |
| DPF6-8580-XL | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
| Polaris 5.5 Spinal System | Biomet Spine | 707 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102488 | 2010-12-10 |
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.