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Quickanchor Ethibond Tapercut 212865

by DePuy Mitek, Inc.

Ref 212865

Quickanchor Ethibond Tapercut 212865 is a device classified as Class IIb in the EU and Class II in the US made by DePuy Mitek, Inc., registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI B-USMF000045334000018TR) and listed in FDA GUDID since 1 Sep 2015 (UDI-DI D-USMF000045334000018TR), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-USMF000045334000018TR Basic UDI-DI D-USMF000045334000018TRUDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-USMF000045334000018TR UDI-DI Date1 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-USMF000045334000018TR registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI D-USMF000045334000018TR listed 1 Sep 2015 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-USMF000045334000018TR
  2. Registered EUDAMED B-USMF000045334000018TR

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  • Withdrawn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
Micro Quickanchor Plus Ethibond Tapercut EUDAMED
Quickanchor Ethibond Tapercut GUDID
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Ref / Catalog
212865
Primary DI / UDI-DI
D-USMF000045334000018TR EUDAMED
10886705002528 GUDID
Basic UDI-DI
B-USMF000045334000018TR
FDA product code
HWC
EMDN code
P09120102 Anchors, tendon and ligament synthesis
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-USMF000045334000018TR
GUDID
10886705002528
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-USMF000045334000018TR; FDA GUDID lists 10886705002528), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Tendon/ligament bone anchor, non-bioabsorbable

Similar devices in this category

Other devices filed under ANCHORS, TENDON AND LIGAMENT SYNTHESIS.

Other devices from DePuy Mitek, Inc.

See all devices from DePuy Mitek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)