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DIAM Spinal Stabilization System

FDA PMA

Class III (US FDA PMA)

PMA P240043

by Companion Spine France SAS

Identity

Trade Name
DIAM­™ Spinal Stabilization System FDA PMA
Generic Name
Prosthesis, spinous process spacer/plate FDA PMA

Identifiers

PMA Number
P240043 FDA PMA
FDA Product Code
NQO FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Orthopedic FDA PMA
FDA Decision
APPR Approved FDA PMA

The DIAM Spinal Stabilization System is a Prosthesis, Spinous Process Spacer/Plate, designed as a dynamic implant for skeletally mature patients with moderate to severe primary low back pain secondary to lumbar degenerative disc disease (DDD) at a single level (L2–L5). Implanted via a minimally invasive posterior approach, it is intended for patients refractory to at least six months of non-operative care, with radiographic confirmation of disc degeneration or structural abnormalities such as reduced disc height or ligamentous scarring.

The system is supplied as a sterile, single-use device and is classified as a Class III medical device under FDA regulations. Authorized under FDA_PMA (PMA P240043), it is intended for surgical use in orthopedic settings. No MRI safety data or reusable variants are specified. Storage and handling must comply with sterile surgical instrument protocols, as outlined in the manufacturer’s instructions for use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DIAM™ Spinal Stabilization System - Companion Spine, DIAM­™ Spinal Stabilization System (P240043) — FDA 510 (k) | Innolitics, DIAM­™ Spinal Stabilization System PMA P240043S001 - FDA.report, DIAM­™ Spinal Stabilization System (P240043) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Companion Spine France SAS

Sources (1)

  • FDA PMA P240043 23 fields · synced Oct 6, 2026