AnyPlus Cervical PEEK Cage System
The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage device consists…
The GS Medical AnyPlus® Cervical PEEK Cage device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical PEEK Cage devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® Cervical PEEK Cage device is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage is designed for interbody stabilization of the cervical spine.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Shanghai Sanyou Medical Co., Ltd. | Shanghai | Shanghai | Manufacturer | 6 |
Record
| Listed by | GS Medical Co., Ltd., South Korea |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Manufacturer |
| 510(k) | K153517 |
| Record published | 2016-08-30 |
| Record revised | 2020-02-24 (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, serial number |
| Distribution end date | 2016-08-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1180-1208 | In distribution | |
| 1182-1406 | In distribution | |
| 1180-1209 | In distribution | |
| 1182-1407 | In distribution | |
| 1180-1206 | In distribution | |
| 1180-1212 | In distribution | |
| 1182-5409 | In distribution | |
| 1180-5210 | In distribution | |
| 1182-5408 | In distribution | |
| 1182-1409 | In distribution | |
| 1180-5205 | In distribution | |
| 1182-5405 | In distribution | |
| 1182-1410 | In distribution | |
| 1182-5407 | In distribution | |
| 1180-5206 | In distribution | |
| 1180-1211 | In distribution | |
| 1180-5212 | In distribution | |
| 1180-1210 | In distribution | |
| 1182-1412 | In distribution | |
| 1180-5207 | In distribution | |
| 1182-1411 | In distribution | |
| 1180-1205 | In distribution | |
| 1182-5412 | In distribution | |
| 1182-1405 | In distribution | |
| 1180-5211 | In distribution | |
| 1180-5208 | In distribution | |
| 1180-1207 | In distribution | |
| 1182-1408 | In distribution | |
| 1180-5209 | In distribution | |
| 1182-5410 | Withdrawn | |
| 1182-5411 | Withdrawn | |
| 1182-5406 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Latitude-C AM™ Cervical Interbody Fusion System | Degen Medical | 1,529 |
| IdentiTi | Alphatec Spine, Inc. | 1,390 |
| Zavation | Zavation | 1,357 |
| IVA Cage Ti | Diomedical Co., Ltd. | 1,202 |
| Latitude-C Cervical Interbody Spacer System | Degen Medical | 1,185 |
| Peridot Anterior Cervical Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 1,056 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,017 |
| Valeo Spacer System | Sintx Technologies Inc. | 918 |
| Cascadia™ Interbody System | VB Spine LLC | 823 |
| CoRoent | Nuvasive, Inc. | 815 |
| Tyber Medical | Tyber Medical | 740 |
| Matisse Anterior Cervical Interbody Fusion Cage System | CTL Medical Corporation | 577 |
Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241738 | 2024-08-20 |
| K200592 | 2020-08-10 |
| K153517 | 2016-06-24 |
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.