EIT CIF Trial
Trial, H 12mm, 4°, XL
7manufacturers in China registered for this device type
53catalogue numbers in this listing
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 | EIT Emerging Implant Technologies Gmbh, Germany |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K170503 |
| Record published | 2018-09-21 |
| Record revised | 2019-02-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CET287XL | In distribution | |
| CET2110S | In distribution | |
| CET2820L | In distribution | |
| CET0050L | In distribution | |
| CET212XL | In distribution | |
| CET2110L | In distribution | |
| CET008XL | In distribution | |
| CET205XL | In distribution | |
| CET0040L | In distribution | |
| CET207XL | In distribution | |
| CET288XL | In distribution | |
| CET0040S | In distribution | |
| CET2120L | In distribution | |
| CET209XL | In distribution | |
| CET0100S | In distribution | |
| CET286XL | In distribution | |
| CET208XL | In distribution | |
| CET0080S | In distribution | |
| CET211XL | In distribution | |
| CET206XL | In distribution | |
| CET0110L | In distribution | |
| CET0070L | In distribution | |
| CET2810L | In distribution | |
| CET284XL | In distribution | |
| CET0050S | In distribution | |
| CET285XL | In distribution | |
| CET004XL | In distribution | |
| CET012XL | In distribution | |
| CET282XL | In distribution | |
| CET007XL | In distribution | |
| CET0120L | In distribution | |
| CET200XL | In distribution | |
| CET2820S | In distribution | |
| CET006XL | In distribution | |
| CET005XL | In distribution | |
| CET0060L | In distribution | |
| CET204XL | In distribution | |
| CET280XL | In distribution | |
| CET0100L | In distribution | |
| CET0090L | In distribution | |
| CET0120S | In distribution | |
| CET2120S | In distribution | |
| CET011XL | In distribution | |
| CET010XL | In distribution | |
| CET009XL | In distribution | |
| CET289XL | In distribution | |
| CET281XL | In distribution | |
| CET0070S | In distribution | |
| CET0090S | In distribution | |
| CET0060S | In distribution | |
| CET0080L | In distribution | |
| CET2810S | In distribution | |
| CET0110S | 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
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.