510(k) K253118
K253118 is an FDA 510(k) premarket notification submitted by Companion Spine France for the device "Companion Spine DIAM Instrumentation". The FDA issued a decision of Substantially Equivalent on Dec 16, 2025. The device falls under product code QLR (Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices), a Class II device regulated under 21 CFR 888.4520.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 16, 2025
- Date Received
- Sep 24, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
- Device Class
- Class II
- Regulation Number
- 888.4520
- Review Panel
- OR
- Submission Type
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.