THE Audere C Spinal Intervetebral Body Fusion Device IS A Cervical Intervetebral Body Fusion Device That IS Implanted Into THE Intervertebral Body Space TO Improve Stability OF THE Spine…
THE Audere C Spinal Intervetebral Body Fusion Device IS A Cervical Intervetebral Body Fusion Device That IS Implanted Into THE Intervertebral Body Space TO Improve Stability OF THE Spine While Supporting Fusion. A Variety OF Implant Sizes ARE Provided TO Accommodate Individual 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.
Record
Regulatory record for Audere C Cervical Implant 5MM X 0° | Listed by | Met 1 Technologies, 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 |
| Record published | 2017-07-10 |
| Record revised | 2020-02-24 (version 3) |
Specifications
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, manufacturing date, serial number |
| Sizes | Angle 0 °; height 5 mm |
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.