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The Tracker / December 2025 / P240043

PMA approved

DIAM Spinal Stabilization System

Companion Spine France Sas · Dec 10, 2025 · P240043

FDA approved the DIAM Spinal Stabilization System from Companion Spine France Sas on Dec 10, 2025 under P240043, an original premarket approval. The device falls under product code NQO, Prosthesis, Spinous Process Spacer/Plate as a Class 3 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 6, 2024. The decision came 369 days later.

Companion Spine France Sas has one other decision in the tracker over the last 12 months: K253118 (Companion Spine DIAM Instrumentation).

Questions & Answers

What did FDA approve under P240043?

P240043 is the FDA PMA for DIAM Spinal Stabilization System, submitted by Companion Spine France Sas. FDA's decision date was Dec 10, 2025, under product code NQO (Prosthesis, Spinous Process Spacer/Plate).

Who makes the DIAM Spinal Stabilization System?

Companion Spine France Sas, based in Merignac, is the applicant of record for P240043.

How long did the P240043 review take?

FDA received the submission on Dec 6, 2024 and issued its decision on Dec 10, 2025, 369 days later.

← All decisions in December 2025