Alamo C Interbody Fusion Device
Alamo C is an anterior cervical interbody fusion implant for skeletally mature patients with degenerative disc disease and accompanying radicular symptoms at one level from C2 to T1.…
Alamo C is an anterior cervical interbody fusion implant for skeletally mature patients with degenerative disc disease and accompanying radicular symptoms at one level from C2 to T1. Patients should have received at least six weeks of nonoperative treatment. The implant requires autograft and supplemental fixation.
The PEEK-OPTIMA implant has a hollow center for bone graft and tantalum markers for radiographic visualization. Ridges on its upper and lower surfaces help resist migration and improve fixation between the adjacent vertebral endplates.
Listed Item
Cervical Interbody Fusion Device, PEEK
Placement
The cage is implanted through an open anterior approach. Different footprints and heights accommodate variation in patient anatomy.
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 | Alliance Partners, LLC, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K133321 |
| Record published | 2017-10-03 |
| Record revised | 2020-02-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 5 to 12 mm; width 14 to 20 mm; length 12 to 16 mm; angle 7 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1714I-708 | Angle 7 ° | In distribution |
| 1714I-010 | Height 10 mm | In distribution |
| 1412I-012 | Height 12 mm | In distribution |
| 1714I-005 | Height 5 mm | In distribution |
| 1412I-711 | Angle 7 ° | In distribution |
| 2016I-710 | Angle 7 ° | In distribution |
| 2016I-706 | Angle 7 ° | In distribution |
| 1412I-712 | Angle 7 ° | In distribution |
| 2016I-005 | Height 5 mm | In distribution |
| 2016I-009 | Height 9 mm | In distribution |
| 1412I-007 | Height 7 mm | In distribution |
| 1714I-009 | Height 9 mm | In distribution |
| 1412I-008 | Height 8 mm | In distribution |
| 1714I-711 | Angle 7 ° | In distribution |
| 1412I-011 | Height 11 mm | In distribution |
| 1714I-707 | Angle 7 ° | In distribution |
| 1412I-010 | Height 10 mm | In distribution |
| 1714I-007 | Height 7 mm | In distribution |
| 2016I-008 | Height 8 mm | In distribution |
| 2016I-707 | Angle 7 ° | In distribution |
| 2016I-010 | Height 10 mm | In distribution |
| 2016I-709 | Height 9 mm | In distribution |
| 2016I-007 | Height 7 mm | In distribution |
| 2016I-711 | Height 11 mm | In distribution |
| 1412I-706 | Angle 7 ° | In distribution |
| 2016I-006 | Height 6 mm | In distribution |
| 1714I-709 | Angle 7 ° | In distribution |
| 1714I-012 | Height 12 mm | In distribution |
| 1714I-008 | Height 8 mm | In distribution |
| 1412I-708 | Height 8 mm | In distribution |
| 1412I-709 | Angle 7 ° | In distribution |
| 1412I-705 | Height 5 mm | In distribution |
| 1412I-707 | Angle 7 ° | In distribution |
| 1412I-710 | Angle 7 ° | In distribution |
| 2016I-012 | Height 12 mm | In distribution |
| 2016I-712 | Height 12 mm | In distribution |
| 1714I-706 | Angle 7 ° | In distribution |
| 2016I-011 | Height 11 mm | In distribution |
| 1714I-705 | Angle 7 ° | In distribution |
| 2016I-705 | Angle 7 ° | In distribution |
| 1714I-712 | Height 12 mm | In distribution |
| 1412I-009 | Height 9 mm | In distribution |
| 1412I-006 | Height 6 mm | In distribution |
| 2016I-708 | Angle 7 ° | In distribution |
| 1714I-710 | Angle 7 ° | In distribution |
| 1714I-006 | Height 6 mm | In distribution |
| 1412I-005 | Height 5 mm | In distribution |
| 1714I-011 | Height 11 mm | In distribution |
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 |
|---|---|
| K173128 | 2018-03-22 |
| K133321 | 2014-01-09 |
| K112361 | 2011-11-30 |
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.