Companion Spine France · Class II · Cleared Dec 16, 2025
| K-number | K253118 |
| Device name | Companion Spine DIAM Instrumentation |
| Applicant | Companion Spine France |
| Product code | QLR |
| Device class | Class II |
| Decision date | Dec 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
The Companion Spine DIAM™ Instrumentation is a set of manual surgical instruments used to insert, position, and remove the Companion Spine DIAM™ Spinal Stabilization System, a non-fusion spinous process spacer device. These are non-implant tools with implant-specific geometry designed for tissue manipulation and device placement during spinal surgery.
The instruments are manual, non-powered surgical tools made of similar materials to the predicate and packaged in similar sterilization trays and containers. They include crimpers and inserters with specific geometries for the DIAM™ system. Both the subject and predicate devices feature manual surgical instruments and sterilization trays designed for non-fusion spinous process spacer implantation.
Not stated in this summary. The document references cadaver model validation and static tensile testing but does not cite specific ISO, IEC, or ASTM consensus standards by designation.
The Companion Spine DIAM™ Instrumentation is substantially equivalent to the coflex Interlaminar Technology Instrumentation predicate because both have the same intended use, similar technological characteristics, are made of similar materials, use similar sterilization methods, and perform equivalent functions for non-fusion spinous process spacer placement without damaging the implant.
View the full FDA submission: accessdata.fda.gov