Apex Spine System
APEX Ti Cannulated Uniplanar Reduction Screw Dia.6.25, 65mm, Self-Tapping
13manufacturers in China registered for this device type
1,193catalogue 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 |
| 510(k) | K132603 |
| 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 |
|---|---|---|
| P6-85100 | In distribution | |
| P6-6275 | In distribution | |
| PR6-7025C-F | In distribution | |
| 5500-CR450D | In distribution | |
| PR6-7090C | In distribution | |
| 5500-110L | In distribution | |
| UF6-4725 | In distribution | |
| U6-6240C | In distribution | |
| MR6-7090C | In distribution | |
| 5500-050 | In distribution | |
| MR6-4755C | In distribution | |
| 5500-030 | In distribution | |
| PR6-7025C-F | In distribution | |
| M6-6285C | In distribution | |
| MF6-4765C | In distribution | |
| MR6-8530C-F | In distribution | |
| PR6-4755 | In distribution | |
| PF6-8570C | In distribution | |
| MR6-5545C | In distribution | |
| UF6-6275 | In distribution | |
| PR6-5545-F | In distribution | |
| PR6-7730-F | In distribution | |
| U6-7025 | In distribution | |
| UF6-4765 | In distribution | |
| MR6-7780C | In distribution | |
| UR6-6265C-F | In distribution | |
| PR6-4775C-F | In distribution | |
| 6000-045ML | In distribution | |
| P6-9250 | In distribution | |
| MR6-4735-F | In distribution | |
| P6-4780C | In distribution | |
| 5500-CR040 | In distribution | |
| PF6-6285C | In distribution | |
| PF6-6225 | In distribution | |
| M6-7750C | In distribution | |
| MR6-8535C-F | In distribution | |
| PR6-6265C | In distribution | |
| UR6-6285C | In distribution | |
| PR6-7740C-F | In distribution | |
| P6-4730C | In distribution | |
| PF6-9250C | In distribution | |
| UF6-5540C | In distribution | |
| PR6-6260-F | In distribution | |
| UR6-4780-F | In distribution | |
| MR6-6285-F | In distribution | |
| U6-5570 | In distribution | |
| MR6-5555C-F | In distribution | |
| P6-8530 | In distribution | |
| M6-6265C | In distribution | |
| P6-6240C | In distribution | |
| U6-7040C | In distribution | |
| UF6-6250C | In distribution | |
| PR6-5560C-F | In distribution | |
| M6-4770 | In distribution | |
| MR6-5540C-F | In distribution | |
| 6000-D6020 | In distribution | |
| MF6-6245 | In distribution | |
| PR6-7080C | In distribution | |
| PR6-6225C | In distribution | |
| P6-6225C | In distribution | |
| S6-55 | In distribution | |
| PR6-4750 | In distribution | |
| PF6-6235C | In distribution | |
| MR6-7050-F | In distribution | |
| PR6-4775-F | In distribution | |
| MR6-4770C | In distribution | |
| M6-5535C | In distribution | |
| UF6-7740 | In distribution | |
| MF6-9255 | In distribution | |
| LH6-7065 | In distribution | |
| TC6-8000 | In distribution | |
| MF6-8545 | In distribution | |
| UR6-6275C-F | In distribution | |
| PF6-4755E | In distribution | |
| PR6-8525-F | In distribution | |
| UF6-7080C | In distribution | |
| PF6-5525E | In distribution | |
| 6000-050ML | In distribution | |
| UR6-7080 | In distribution | |
| MR6-6235C-F | In distribution | |
| PF6-7060C | In distribution | |
| PR6-7780-F | In distribution | |
| UF6-5525C | In distribution | |
| MR6-4740 | In distribution | |
| PR6-6240 | In distribution | |
| PR6-5545 | In distribution | |
| MF6-5580C | In distribution | |
| UR6-6245 | In distribution | |
| PR6-6285-F | In distribution | |
| UR6-5525C | In distribution | |
| PR6-5585C | In distribution | |
| P60-102 | In distribution | |
| MR6-5565-F | In distribution | |
| MF6-4755C | In distribution | |
| PR6-4775C-F | In distribution | |
| P6-7790C | In distribution | |
| UR6-6250C | In distribution | |
| P6-4785C | In distribution | |
| MF6-10080C | In distribution | |
| MF6-10040 | In distribution | |
| MF6-4770 | In distribution | |
| P6-5585C | In distribution | |
| MF6-10070 | In distribution | |
| PR6-6225C-F | In distribution | |
| MF6-4750C | In distribution | |
| U6-6270 | In distribution | |
| MR6-5575-F | In distribution | |
| MR6-5540-F | In distribution | |
| PR6-6285 | In distribution | |
| MF6-4780 | In distribution | |
| U6-4780 | In distribution | |
| P6-8545 | In distribution | |
| MR6-8590-F | In distribution | |
| P6-5525C | In distribution | |
| S6-54 | In distribution | |
| TC6-2000 | In distribution | |
| P6-10050 | In distribution | |
| MF6-10055C | In distribution | |
| UF6-7035C | In distribution | |
| MR6-7080-F | In distribution | |
| PR6-7045-F | In distribution | |
| MR6-6255C | In distribution | |
| P6-6285 | In distribution | |
| PF6-6235 | In distribution | |
| MR6-4740-F | In distribution | |
| MR6-4730C-F | In distribution | |
| MF6-8535C | In distribution | |
| MR6-7050 | In distribution | |
| UF6-6225 | In distribution | |
| UR6-7025 | In distribution | |
| PF6-7060 | In distribution | |
| TX6-2833 | In distribution | |
| M6-10035C | In distribution | |
| UR6-4755 | In distribution | |
| PR6-8550C | In distribution | |
| PR6-7080C-F | In distribution | |
| PR6-8555C-F | In distribution | |
| UR6-5580C | In distribution | |
| PF6-5560C | In distribution | |
| MF6-4785C | In distribution | |
| M6-5540C | In distribution | |
| PF6-9260 | In distribution | |
| PF6-6275C | In distribution | |
| PF6-6270C | In distribution | |
| PR6-7725C-F | In distribution | |
| M6-5525C | In distribution | |
| P6-7725C | In distribution | |
| P6-8530C | In distribution | |
| UF6-6225C | In distribution | |
| M6-8530C | In distribution | |
| PR6-4745C | In distribution | |
| UR6-4735C-F | In distribution | |
| PR6-4730 | In distribution | |
| PF6-4770C | In distribution | |
| PF6-6250E | In distribution | |
| OR6-5080 | In distribution | |
| PR6-5565 | In distribution | |
| U6-5580 | In distribution | |
| MR6-77100C-F | In distribution | |
| UF6-7060 | In distribution | |
| P6-4745 | In distribution | |
| MR6-7060-F | In distribution | |
| MF6-7090C | In distribution | |
| UR6-6255C-F | In distribution | |
| P6-7745 | In distribution | |
| M6-100100C | In distribution | |
| P6-6265E | In distribution | |
| M6-5550C | In distribution | |
| MR6-7725C-F | In distribution | |
| UF6-7790C | In distribution | |
| P6-7055 | In distribution | |
| PR6-6260C-F | In distribution | |
| M6-7035C | In distribution | |
| MR6-7080C-F | In distribution | |
| PR6-4745C-F | In distribution | |
| MR6-4730C | In distribution | |
| P6-4760C | In distribution | |
| P6-10060C | In distribution | |
| PF6-7745C | In distribution | |
| PF6-7035C | In distribution | |
| PF6-7040 | In distribution | |
| PR6-6270 | In distribution | |
| PF6-8535C | In distribution | |
| PR6-7035C | In distribution | |
| P6-4725C | In distribution | |
| MF6-6240C | In distribution | |
| PR6-7050 | In distribution | |
| PR6-4760C | In distribution | |
| U6-4750 | In distribution | |
| MR6-5560C-F | In distribution | |
| P6-4750E | In distribution | |
| P6-4725 | In distribution | |
| PF6-5540C | In distribution | |
| PR6-7770C | In distribution | |
| M6-7760C | In distribution | |
| PR6-8525 | In distribution | |
| 5500-325 | In distribution | |
| M6-5565C | In distribution | |
| PR6-7780 | In distribution | |
| 5500-CR045 | In distribution | |
| M6-6235C | In distribution | |
| M6-4730C | In distribution | |
| UF6-7740C | In distribution | |
| MR6-5535 | In distribution | |
| MR6-8530C | In distribution | |
| P6-8560C | In distribution | |
| MR6-7080 | In distribution | |
| UR6-5575-F | In distribution | |
| PF6-7045C | In distribution | |
| MR6-7030-F | In distribution | |
| U6-5575 | In distribution | |
| MR6-6240C-F | In distribution | |
| PR6-6255 | In distribution | |
| U6-6265 | In distribution | |
| MF6-7790C | In distribution | |
| U6-5530C | In distribution | |
| 5500-CR300 | In distribution | |
| MF6-5535C | In distribution | |
| MF6-6255C | In distribution | |
| UR6-6260C-F | In distribution | |
| 5500-CR325 | In distribution | |
| MF6-5545C | In distribution | |
| PF6-77100C | In distribution | |
| UR6-4785C | In distribution | |
| U6-8550 | In distribution | |
| MR6-6225C | In distribution | |
| 6000-450 | In distribution | |
| MR6-4735C-F | In distribution | |
| PF6-10025C | In distribution | |
| M6-6270C | In distribution | |
| P6-7045C | In distribution | |
| PF6-9250 | In distribution | |
| UF6-6270 | In distribution | |
| PF6-4740E | In distribution | |
| U6-6285 | In distribution | |
| PR6-7740C | In distribution | |
| P6-5575C | In distribution | |
| PR6-5585 | In distribution | |
| MR6-7040C-F | In distribution | |
| PR6-8545C-F | In distribution | |
| MF6-6250C | In distribution | |
| M6-4745C | In distribution | |
| P6-10040 | In distribution | |
| U6-5550 | In distribution | |
| PR6-8590C-F | In distribution | |
| U6-7760 | In distribution | |
| PF6-8540 | In distribution | |
| MF6-7780C | In distribution | |
| M6-7755 | In distribution | |
| P6-6270C | 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 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| 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.