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…

Registry build 21.09.26

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.

13manufacturers in China registered for this device type
204catalogue 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.

Chinese manufacturers registered for FDA product code MNH
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

Regulatory record for AnyPlus Spinal Fixation System
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

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 numbers for AnyPlus Spinal Fixation System
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
0942-7000 In distribution
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
1624-0511 In distribution
2712-6560-A0 In distribution
0982-8075 In distribution
2722-7045 In distribution
2711-5530-A0 In distribution
0942-7580 In distribution
2712-6530-A0 In distribution
2712-6060-A0 In distribution
2712-7575 In distribution
2722-6045 In distribution
1610-0804 In distribution
2722-7575 In distribution
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
2712-7555 In distribution
0982-8565 In distribution
1641-0507 In distribution
0911-4030 In distribution
0942-7590 In distribution
1630-0809 In distribution
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
2712-7540-A0 In distribution
2722-6575 In distribution
2722-7095 In distribution
2722-7025 In distribution
2921-6090 Withdrawn
2921-8060 Withdrawn
2921-7530 Withdrawn
9256-0280-M0 Withdrawn
2921-6080 Withdrawn
2921-7000 Withdrawn
2921-8030 Withdrawn
2921-7570 Withdrawn
2921-8090 Withdrawn
2921-7550 Withdrawn
2921-7070 Withdrawn
2921-6590 Withdrawn
2921-6580 Withdrawn
2921-7500 Withdrawn
2921-7040 Withdrawn
2921-8070 Withdrawn
2921-8080 Withdrawn
2921-6560 Withdrawn
2921-6070 Withdrawn
2921-6500 Withdrawn
2921-8050 Withdrawn
2921-7050 Withdrawn
2921-6060 Withdrawn
2921-7560 Withdrawn
2921-7540 Withdrawn
2921-7590 Withdrawn
2921-7060 Withdrawn
2921-6000 Withdrawn
2921-6530 Withdrawn
2921-7580 Withdrawn
2921-6540 Withdrawn
2921-7090 Withdrawn
2921-6570 Withdrawn
9256-0300-M0 Withdrawn
2921-7030 Withdrawn
2921-6550 Withdrawn
2921-7080 Withdrawn
2921-8040 Withdrawn

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer