The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone…
The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: – A ligament allowing correction and stabilization of the levels, after tensioning – A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. – A low-profile connector holding the tension on the ligament
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for ResCUBE™ | Listed by | Cousin Biotech, France |
| FDA product code | OWI |
| Device type | Bone Fixation Cerclage, Sublaminar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3010 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K181799 |
| Record published | 2024-01-05 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature i |
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.