Apex-DL Spine System
APEX Ti Cannulated Double Lead Thread Uniplanar Reduction Screw Dia.7.00, 50mm, Self-Tapping
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Spinecraft LLC, United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| 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 |
|---|---|---|
| DPF6-10045 | In distribution | |
| DMF6-5580C | In distribution | |
| DUF6-4780C | In distribution | |
| DUF6-7040 | In distribution | |
| DPF6-8550 | In distribution | |
| DM6-6250 | In distribution | |
| DPF6-9270C | In distribution | |
| DPR6-7090C | In distribution | |
| DMF6-6270C | In distribution | |
| DPR6-7745 | In distribution | |
| DP6-4735C | In distribution | |
| DM6-6255C | In distribution | |
| DMF6-5565 | In distribution | |
| DU6-4775C | In distribution | |
| DP6-6230C | In distribution | |
| DM6-5550 | In distribution | |
| DU6-8535 | In distribution | |
| DP6-7050 | In distribution | |
| DP6-6285C | In distribution | |
| DPR6-7060C | In distribution | |
| DUR6-6280C | In distribution | |
| DUF6-7030 | In distribution | |
| DMF6-92100C | In distribution | |
| DMR6-4755C-F | In distribution | |
| DMR6-5575C | In distribution | |
| DUF6-5560C | In distribution | |
| DMR6-8560-F | In distribution | |
| DMR6-7060 | In distribution | |
| DPR6-8535-F | In distribution | |
| DPR6-6260 | In distribution | |
| DU6-4740 | In distribution | |
| DMR6-4730-F | In distribution | |
| DMF6-10060C | In distribution | |
| DUF6-7025C | In distribution | |
| DPF6-77100 | In distribution | |
| DUF6-8550 | In distribution | |
| DMR6-6240 | In distribution | |
| DM6-4725 | In distribution | |
| DM6-4760 | In distribution | |
| DU6-7790 | In distribution | |
| DU6-70100 | In distribution | |
| DUF6-8535C | In distribution | |
| DMR6-5575 | In distribution | |
| DM6-10080C | In distribution | |
| DMR6-8555C | In distribution | |
| DPF6-4765C | In distribution | |
| DMR6-8535C-F | In distribution | |
| DPF6-7045 | In distribution | |
| DPR6-4780-F | In distribution | |
| DM6-6265C | In distribution | |
| DP6-7035 | In distribution | |
| DUR6-5585C | In distribution | |
| DUR6-7045-F | In distribution | |
| DPF6-6240C | In distribution | |
| DMF6-5575C | In distribution | |
| DPR6-7780C-F | In distribution | |
| DUF6-4745 | In distribution | |
| DPF6-9230 | In distribution | |
| DM6-7035C | In distribution | |
| DP6-10035C | In distribution | |
| DPR6-7025-F | In distribution | |
| DMR6-6270-F | In distribution | |
| DMF6-8555 | In distribution | |
| DPF6-8525C | In distribution | |
| DU6-7760C | In distribution | |
| DPR6-6245C-F | In distribution | |
| DUF6-6275C | In distribution | |
| DMF6-6275 | In distribution | |
| DP6-6260C | In distribution | |
| DM6-8525 | In distribution | |
| DPF6-4780 | In distribution | |
| DU6-4765 | In distribution | |
| DMF6-7770C | In distribution | |
| DMR6-8540C-F | In distribution | |
| DPR6-7055C | In distribution | |
| DMF6-9250 | In distribution | |
| DP6-6225C | In distribution | |
| DPF6-9240C | In distribution | |
| DM6-9260 | In distribution | |
| DP6-7090 | In distribution | |
| DMR6-8525-F | In distribution | |
| DM6-8535 | In distribution | |
| DPF6-7735 | In distribution | |
| DP6-7770C | In distribution | |
| DU6-4745 | In distribution | |
| DMF6-7090 | In distribution | |
| DUR6-4755C | In distribution | |
| DMR6-8570-F | In distribution | |
| DPR6-5570 | In distribution | |
| DUR6-5570 | In distribution | |
| DMR6-8525C | In distribution | |
| DPF6-8580C | In distribution | |
| DPF6-7050C | In distribution | |
| DM6-8580 | In distribution | |
| DPF6-8530-XL | In distribution | |
| DPR6-4770C-F | In distribution | |
| DMF6-7060 | In distribution | |
| DPR6-5580C | In distribution | |
| DMF6-10040C | In distribution | |
| DPF6-6285C | In distribution | |
| DPR6-7040C-F | In distribution | |
| DMR6-7735 | In distribution | |
| DPF6-8555 | In distribution | |
| DU6-6260 | In distribution | |
| DUF6-7745C | In distribution | |
| DUF6-7760C | In distribution | |
| DP6-8550C | In distribution | |
| DU6-7035 | In distribution | |
| DUR6-6280 | In distribution | |
| DMR6-6235C | In distribution | |
| DUF6-8580C | In distribution | |
| DMR6-77100-F | In distribution | |
| DU6-7045 | In distribution | |
| DPF6-7770 | In distribution | |
| DPR6-7070-F | In distribution | |
| DP6-8580 | In distribution | |
| DPR6-7780C | In distribution | |
| DU6-4775 | In distribution | |
| DMR6-6250-F | In distribution | |
| DPR6-7070C-F | In distribution | |
| DMF6-10040 | In distribution | |
| DM6-4780C | In distribution | |
| DUF6-7045 | In distribution | |
| DPR6-6235C | In distribution | |
| DU6-7740 | In distribution | |
| DUR6-4755-F | In distribution | |
| DP6-4755C | In distribution | |
| DPF6-8540-XL | In distribution | |
| DMF6-4725 | In distribution | |
| DMF6-5560 | In distribution | |
| DUF6-5570 | In distribution | |
| DUR6-4785-F | In distribution | |
| DUR6-6260C | In distribution | |
| DMR6-4740 | In distribution | |
| DP6-9290 | In distribution | |
| DMR6-4730C-F | In distribution | |
| DUR6-5545C | In distribution | |
| DU6-6250C | In distribution | |
| DM6-6270 | In distribution | |
| DMR6-4735C | In distribution | |
| DPF6-7770C | In distribution | |
| DP6-7735 | In distribution | |
| DPR6-5570C | In distribution | |
| DU6-7090 | In distribution | |
| DPR6-5560C | In distribution | |
| DMF6-5585 | In distribution | |
| DUR6-4740C | In distribution | |
| DUR6-7050C-F | In distribution | |
| DPF6-8540C | In distribution | |
| DPF6-4740C | In distribution | |
| DUF6-6225 | In distribution | |
| DPF6-7025 | In distribution | |
| DMF6-7025 | In distribution | |
| DMR6-6275-F | In distribution | |
| DUR6-7080 | In distribution | |
| DUR6-5565-F | In distribution | |
| DP6-9260C | In distribution | |
| DUF6-7060C | In distribution | |
| DPR6-4740C-F | In distribution | |
| DPF6-6285 | In distribution | |
| DM6-8545 | In distribution | |
| DMR6-7040 | In distribution | |
| DU6-7045C | In distribution | |
| DUF6-7050C | In distribution | |
| DM6-5540 | In distribution | |
| DPR6-5525 | In distribution | |
| DUR6-5560 | In distribution | |
| DM6-7730C | In distribution | |
| DP6-4780 | In distribution | |
| DPF6-7080C | In distribution | |
| DMF6-9225C | In distribution | |
| DMF6-6255 | In distribution | |
| DPR6-5555C | In distribution | |
| DM6-8530 | In distribution | |
| DP6-7070C | In distribution | |
| DUF6-7750 | In distribution | |
| DMR6-5560C | In distribution | |
| DM6-92100 | In distribution | |
| DP6-9240C | In distribution | |
| DUF6-7730 | In distribution | |
| DMF6-8580 | In distribution | |
| DMF6-7770 | In distribution | |
| DP6-6250C | In distribution | |
| DMF6-9280 | In distribution | |
| DPR6-5540-F | In distribution | |
| DM6-9230C | In distribution | |
| DMR6-5525C-F | In distribution | |
| DMR6-4755C | In distribution | |
| DMF6-8555C | In distribution | |
| DMF6-5565C | In distribution | |
| DUR6-6260-F | In distribution | |
| DMF6-5555 | In distribution | |
| DPF610055C | In distribution | |
| DMF6-8545 | In distribution | |
| DMF6-4770 | In distribution | |
| DPR6-7080C | In distribution | |
| DP6-100100C | In distribution | |
| DUR6-5540C | In distribution | |
| DPF6-5560 | In distribution | |
| DPF6-7050 | In distribution | |
| DM6-10080 | In distribution | |
| DP6-10025C | In distribution | |
| DUF6-8570C | In distribution | |
| DP6-5570C | In distribution | |
| DPR6-7040-F | In distribution | |
| DU6-8545 | In distribution | |
| DPR6-7760C | In distribution | |
| DM6-4775C | In distribution | |
| DMR6-4780C-F | In distribution | |
| DU6-5530 | In distribution | |
| DMR6-7790C | In distribution | |
| DPR6-7750C-F | In distribution | |
| DU6-4760C | In distribution | |
| DMR6-4740C | In distribution | |
| DM6-7050 | In distribution | |
| DMF6-8570 | In distribution | |
| DU6-7090C | In distribution | |
| DPR6-8570C | In distribution | |
| DP6-7740 | In distribution | |
| DUF6-8540 | In distribution | |
| DPF6-10070 | In distribution | |
| DMF6-77100 | In distribution | |
| DUR6-6270-F | In distribution | |
| DPR6-6265C | In distribution | |
| DP6-9235C | In distribution | |
| DMR6-8540 | In distribution | |
| DMF6-4730 | In distribution | |
| DPR6-6275C-F | In distribution | |
| DP6-6245C | In distribution | |
| DUR6-7055 | In distribution | |
| DUR6-5540-F | In distribution | |
| DMF6-5540 | In distribution | |
| DUR6-5560-F | In distribution | |
| DMR6-6280-F | In distribution | |
| DPR6-8570-F | In distribution | |
| DU6-5570C | In distribution | |
| DMF6-4775 | In distribution | |
| DUR6-7045C | In distribution | |
| DP6-6280C | In distribution | |
| DPR6-6250C-F | In distribution | |
| DPR6-8535C-F | In distribution | |
| DMF6-7740 | In distribution | |
| DU6-6285C | In distribution | |
| DPF6-4770 | In distribution | |
| DMR6-70100-F | In distribution | |
| DPR6-4780 | In distribution | |
| DMR6-7790C-F | In distribution | |
| DMR6-8555C-F | In distribution | |
| DM6-10060C | In distribution | |
| DPR6-5560-F | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
| Polaris 4.75 TI Spinal System | Biomet Spine | 256 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
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.