510(k) K253118

Companion Spine DIAM Instrumentation by Companion Spine France — Product Code QLR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 16, 2025
Date Received: September 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.