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TaperFit Cemented Hip System 340.400

by Corin Ltd

Ref 340.400Model MetaFix Hip Stem Instrument Set

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05055196968608 Basic UDI-DI 05055196968608UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055196968608 UDI-DI Date17 Aug 2016ListedStatusListed GUDID: in commercial distribution

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-1667-2022 FDA Class II initiated 12 Jul 2022

    Some of the devices did not pass fatigue testing.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Head Pusher EUDAMED
TaperFit Cemented Hip System GUDID
Generic Name
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
340.400, MetaFix Hip Stem Instrument Set
Primary DI / UDI-DI
05055196968608
Basic UDI-DI
B-05055196968608
510(k) Number
FDA Product Code
JDG, JDI
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3360, 888.3350
EU market of registration
Italy
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 I
GUDID
Class II

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K142761)

Show all (12)

Other devices from Corin Ltd

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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