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coflex-F trial, 8mm RCT00008

by Paradigm Spine, LLC EUDAMEDGUDID

Active European Union

Ref RCT00008

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04260148890277 Basic UDI-DIDate21 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED NumberB-04260148890277 Basic UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260148890277 UDI-DIDate29 Jun 2017ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · FDA

    • Terminated Z-0412-2013 FDA Class II initiated 28 Aug 2012

    Inspan Compressors may break at weld causing a loss of compression

Specification

EUDAMED · GUDID

Trade Name
CoFix™ EUDAMED
coflex-F trial, 8mm GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Name
coflex-F™ trial, 8mm
Model / Reference
RCT00008
Primary DI / UDI-DI
04260148890277
Basic UDI-DI
B-04260148890277, 0426014889018-043D
Direct Marketing DI
04260148890277
510(k) Number
FDA Product Code
KWP
EMDN Code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3050
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K093438)

Show all (12)

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Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No