AnyPlus Spinal Fixation System
The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. The components are manufactured from Ti6AI4V…
The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. The components are manufactured from Ti6AI4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1 -S2), a posterior hook fixation system (T 1-5), or as a anterolateral fixation system (T8-L_5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
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 | GS Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer |
| 510(k) | K091717 |
| Record published | 2015-11-10 |
| Record revised | 2025-07-02 (version 4) |
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, manufacturing date, serial number |
| Distribution end date | 2016-06-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0982-8085 | In distribution | |
| 0942-7070 | In distribution | |
| 0982-7565 | In distribution | |
| 2712-7530-A0 | In distribution | |
| 2712-6580-A0 | In distribution | |
| 0982-7095 | In distribution | |
| 2722-7035 | In distribution | |
| 2712-6090-A0 | In distribution | |
| 1621-0504 | In distribution | |
| 0942-7530 | In distribution | |
| 0982-7085 | In distribution | |
| 0911-4040 | In distribution | |
| 0982-8595 | In distribution | |
| 2722-5555 | In distribution | |
| 2722-6525 | In distribution | |
| 0942-7570 | In distribution | |
| 0982-7575 | In distribution | |
| 2722-7555 | In distribution | |
| 0982-7035 | In distribution | |
| 2712-6080-A0 | In distribution | |
| 2712-6590-A0 | In distribution | |
| 0982-7535 | In distribution | |
| 0921-6555 | In distribution | |
| 0942-7080 | In distribution | |
| 1622-0704 | In distribution | |
| 0982-8525 | In distribution | |
| 2712-7560-A0 | In distribution | |
| 0942-7540 | In distribution | |
| 0942-6590 | In distribution | |
| 2722-5045 | In distribution | |
| 2722-6535 | In distribution | |
| 1624-0505 | In distribution | |
| 2722-6595 | In distribution | |
| 2712-6550-A0 | In distribution | |
| 2722-6585 | In distribution | |
| 0982-8035 | In distribution | |
| 2711-5550-A0 | In distribution | |
| 0942-7500 | In distribution | |
| 2712-7050-A0 | In distribution | |
| 2722-7545 | In distribution | |
| 0983-5025 | In distribution | |
| 2712-7590-A0 | In distribution | |
| 0982-8055 | In distribution | |
| 0921-5545 | In distribution | |
| 0982-8065 | In distribution | |
| 0983-5065 | In distribution | |
| 0942-7560 | In distribution | |
| 2722-5055 | In distribution | |
| 2712-6030-A0 | In distribution | |
| 0982-7525 | In distribution | |
| 2722-6555 | In distribution | |
| 2711-5030-A0 | In distribution | |
| 2712-7000-A0 | In distribution | |
| 2722-6095 | In distribution | |
| 0942-6500 | In distribution | |
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| 2722-6065 | In distribution | |
| 1625-0505 | In distribution | |
| 2722-5535 | In distribution | |
| 2722-7595 | In distribution | |
| 2722-7565 | In distribution | |
| 2712-7080-A0 | In distribution | |
| 0982-8025 | In distribution | |
| 2711-5050-A0 | In distribution | |
| 0942-7050 | In distribution | |
| 0982-8585 | In distribution | |
| 0982-8575 | In distribution | |
| 2712-7570-A0 | In distribution | |
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| 2712-6560-A0 | In distribution | |
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| 2712-6530-A0 | In distribution | |
| 2712-6060-A0 | In distribution | |
| 2712-7575 | In distribution | |
| 2722-6045 | In distribution | |
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| 0942-7040 | In distribution | |
| 0982-8045 | In distribution | |
| 0983-5535 | In distribution | |
| 0983-5525 | In distribution | |
| 2712-7550-A0 | In distribution | |
| 0982-7585 | In distribution | |
| 0982-7075 | In distribution | |
| 0942-7060 | In distribution | |
| 0982-7545 | In distribution | |
| 0921-7540 | In distribution | |
| 2722-6565 | In distribution | |
| 2711-5040-A0 | In distribution | |
| 2712-7580-A0 | In distribution | |
| 2722-5565 | In distribution | |
| 2712-7060-A0 | In distribution | |
| 2712-7585 | In distribution | |
| 2722-6055 | In distribution | |
| 2722-7055 | In distribution | |
| 2712-7070-A0 | In distribution | |
| 1610-0807 | In distribution | |
| 0942-7090 | In distribution | |
| 2722-7535 | In distribution | |
| 2712-6500-A0 | In distribution | |
| 2722-7065 | In distribution | |
| 0982-7595 | In distribution | |
| 2712-6040-A0 | In distribution | |
| 2711-5560-A0 | In distribution | |
| 2712-6000-A0 | In distribution | |
| 2712-6050-A0 | In distribution | |
| 2722-7525 | In distribution | |
| 2722-6085 | In distribution | |
| 0982-8545 | In distribution | |
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| 2712-6070-A0 | In distribution | |
| 2722-5525 | In distribution | |
| 2712-7565 | In distribution | |
| 2711-5070-A0 | In distribution | |
| 2712-7090-A0 | In distribution | |
| 2712-6570-A0 | In distribution | |
| 0982-8095 | In distribution | |
| 2722-6025 | In distribution | |
| 0942-7030 | In distribution | |
| 2722-7075 | In distribution | |
| 2722-7085 | In distribution | |
| 2712-7595 | In distribution | |
| 2722-5065 | In distribution | |
| 2722-5025 | In distribution | |
| 2722-7585 | In distribution | |
| 0982-7025 | In distribution | |
| 0921-5540 | In distribution | |
| 0941-7535 | In distribution | |
| 0982-7045 | In distribution | |
| 0983-5045 | In distribution | |
| 0983-5055 | In distribution | |
| 2712-7500-A0 | In distribution | |
| 0982-8555 | In distribution | |
| 2722-6075 | In distribution | |
| 2712-6540-A0 | In distribution | |
| 0942-7550 | In distribution | |
| 1622-0707 | In distribution | |
| 2711-5060-A0 | In distribution | |
| 0983-5035 | In distribution | |
| 2722-5035 | In distribution | |
| 2712-7030-A0 | In distribution | |
| 2712-7040-A0 | In distribution | |
| 0982-7065 | In distribution | |
| 0982-8535 | In distribution | |
| 1622-0709 | In distribution | |
| 2722-5545 | In distribution | |
| 2722-6035 | In distribution | |
| 2711-5540-A0 | In distribution | |
| 0982-7055 | In distribution | |
| 1623-0511 | In distribution | |
| 0921-7535 | In distribution | |
| 0982-7555 | In distribution | |
| 1310-5015 | In distribution | |
| 2712-7545 | In distribution | |
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| 2722-7095 | In distribution | |
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| 2921-6090 | Withdrawn | |
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| 9256-0300-M0 | Withdrawn | |
| 2921-7030 | Withdrawn | |
| 2921-6550 | Withdrawn | |
| 2921-7080 | Withdrawn | |
| 2921-8040 | Withdrawn |
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 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053573 | 2006-03-08 |
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.