COMPANION SPINE

FDA Device Registration & Listing · Merignac Gironde, FR · Registration 3025435185

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3025435185
FEI Number
3025435185
Entity Name
COMPANION SPINE
City/State/Country
Merignac Gironde, FR
Establishment Address
Immeuble le Bridge - 5 Allee des Acacias, Merignac Gironde 33700, FR
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Companion Spine (Owner Number: 10086759)
Owner / Operator Contact Address
Immeuble le Bridge - 5 Allee des Acacias, Mérignac, FR-33 33700, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253118
PMA Number
N/A

All Registered Proprietary Names

Coflex Interlaminar Technology Cofix System Companion Spine DIAM Instrumentation

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NQO Prosthesis, Spinous Process Spacer/Plate Unknown Class 3 N/A 2025-12-04
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2025-12-04
QLR Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices Orthopedic Class 2 888.4520 2025-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

Bill PFOST Email: bill.pfost@companion-spine.com Phone: (949) 4124091

Related Public Records

Same Entity

Companion Spine
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3005426761 Paradigm Spine GmbH Wurmlingen Baden-Wurttemberg, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025435185. Last updated year: 2026. Please use registration number 3025435185 when referencing this establishment in official correspondence.
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