K253118 is an FDA 510(k) clearance for the Companion Spine DIAM™ Instrumentation. This device is classified as a Manual Instruments Designed For Use With Non-fusion Spinous Process Spacer Devices (Class II - Special Controls, product code QLR).
Submitted by Companion Spine France (Mérignac, FR). The FDA issued a Cleared decision on December 16, 2025, 83 days after receiving the submission on September 24, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4520. The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Placement, Or Removal Of Spinous Process Spacer Devices For Non-fusion Use..
| 510(k) Number | K253118 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2025 |
| Decision Date | December 16, 2025 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QLR - Manual Instruments Designed For Use With Non-fusion Spinous Process Spacer Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4520 |
| Definition | The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Placement, Or Removal Of Spinous Process Spacer Devices For Non-fusion Use. |