510(k) K253118

Device

Companion Spine DIAM™ Instrumentation

Applicant

Companion Spine France

510(k) number

K253118

Product code

QLR

Decision

Substantially Equivalent (SESE)

Decision date

2025-12-16

Date received

2025-09-24

Regulation

888.4520

Classification name

Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

Medical specialty

Orthopedic

Review panel

Orthopedic

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

N