Companion Spine DIAM Instrumentation— 510(k) K253118

Name: FDA 510(k) clearance K253118
Creator: U.S. Food and Drug Administration
Published: 2025-12-16

Substantially Equivalent

Companion Spine France

FDA 510(k) clearance K253118 for Companion Spine DIAM Instrumentation, Substantially Equivalent on 2025-12-16. Applicant: Companion Spine France. Device class: 2.

Clearance details

Applicant: Companion Spine France
Product code: Code QLR
Device class: Class 2
Regulation: 21 CFR 888.4520
Advisory panel: Orthopedic
Date received: 2025-09-24
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mérignac, FR

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