Cervical Interbody Fusion System
Cervical Interbody Fusion System from Evolution Spine is an anterior cervical implant system for fusion at one disc level between C2-C3 and C7-T1. It is intended for skeletally mature…
Cervical Interbody Fusion System from Evolution Spine is an anterior cervical implant system for fusion at one disc level between C2-C3 and C7-T1. It is intended for skeletally mature patients with degenerative disc disease confirmed by patient history and imaging.
The system includes implants made with VESTAKEEP PEEK and tantalum, along with instruments for placement. Different sizes accommodate patient anatomy. The implants are single use and the system is supplied nonsterile.
Listed Item
Cervical IBD, 14x16x14mm, 10 Deg
Treatment Conditions
Use requires supplemental fixation and autograft to support fusion. Patients should have received at least six weeks of nonoperative treatment before an intervertebral cage is used. The implant provides mechanical stability in the cervical disc space while biological fusion develops.
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 | Evolution Spine, 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 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K160324 |
| Record published | 2021-05-25 |
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 14 mm; angle 6 to 10 °; depth 14 to 16 mm; width 12 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CLP1009 | Height 9 mm | In distribution |
| CLP1014 | Depth 16 mm | In distribution |
| CLP0606 | Height 6 mm | In distribution |
| CLP0614 | Angle 6 ° | In distribution |
| CSP1006 | Angle 10 ° | In distribution |
| CSP1007 | Height 7 mm | In distribution |
| CSP1009 | Width 12 mm | In distribution |
| CLP1007 | Angle 10 ° | In distribution |
| CSP6007 | Depth 14 mm | In distribution |
| CLP0607 | Width 14 mm | In distribution |
| CLP1006 | Depth 16 mm | In distribution |
| CSP6014 | Width 12 mm | In distribution |
| CLP1011 | Angle 10 ° | In distribution |
| CSP6009 | Width 12 mm | In distribution |
| CSP6010 | Depth 14 mm | In distribution |
| CLP1008 | Height 8 mm | In distribution |
| CLP0610 | Depth 16 mm | In distribution |
| CLP0611 | Angle 6 ° | In distribution |
| CSP1008 | Height 8 mm | In distribution |
| CSP6006 | Depth 14 mm | In distribution |
| CSP1014 | Width 12 mm | In distribution |
| CSP6005 | Depth 14 mm | In distribution |
| CSP6011 | Height 11 mm | In distribution |
| CSP1010 | Depth 14 mm | In distribution |
| CLP1013 | Height 13 mm | In distribution |
| CSP1012 | Angle 10 ° | In distribution |
| CLP0613 | Depth 16 mm | In distribution |
| CLP1010 | Width 14 mm | In distribution |
| CSP1013 | Depth 14 mm | In distribution |
| CSP6012 | Width 12 mm | In distribution |
| CLP0608 | Width 14 mm | In distribution |
| CLP0605 | Depth 16 mm | In distribution |
| CLP0609 | Angle 6 ° | In distribution |
| CLP1012 | Height 12 mm | In distribution |
| CSP1011 | Depth 14 mm | In distribution |
| CLP0612 | Width 14 mm | In distribution |
| CSP6008 | Angle 6 ° | In distribution |
| CSP6013 | Depth 14 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 |
|---|---|
| K160324 | 2016-05-05 |
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.