Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005426761

FEI Number

3005426761

Entity Name

Paradigm Spine GmbH

City/State/Country

Wurmlingen Baden-Wurttemberg, DE

Establishment Address

Eisenbahnstrabe 84, Wurmlingen Baden-Wurttemberg 78573, DE

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

Expiration Date (Year)

2026

510(k) Number

K153302

PMA Number

N/A

All Registered Proprietary Names

Coflex Interlaminar Technology Coflex-F Implant System Coflex-IF

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
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-12-04
PEK	Spinous Process Plate	Orthopedic	Class 2	888.3050	2025-12-04

Official Correspondent

Ratsamy Thevenin

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
3025435185	COMPANION SPINE	Merignac Gironde, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

Registration Number	Establishment Name	Location
3025435185	COMPANION SPINE	Merignac Gironde, FR
3010160527	Synergy Health Allershausen GmbH	Allershausen Bavaria, DE
2953359	Sterigenics U.S. LLC	Hayward, CA, US
3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
3010173425	Synergy Health Westport Ltd	Westport Mayo, IE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005426761. Last updated year: 2026. Please use registration number 3005426761 when referencing this establishment in official correspondence.