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DWD060

by Tornier, Inc.

Ref DWD060Model 08858251027973VK

DWD060 is a device classified as Class IIa in the EU and Class I in the US made by Tornier, Inc., registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 08858251027973VK) and listed in FDA GUDID since 8 Aug 2022 (UDI-DI 03700386931789), active as of 24 Oct 2026.

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

CE MDR

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/MDR EUDAMED Number08858251027973VK Basic UDI-DI 03700386931789UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700386931789 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251027973VK registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 03700386931789 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700386931789
  2. Registered EUDAMED 08858251027973VK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Aequalis® Reversed II
Generic name
Drilling power tool attachment, basic
Device name
Aequalis Reversed II Instrumentation - Drilling Instrumentation - Class Iia - Sterile
Model / Ref / Catalog
DWD060, 08858251027973VK
Primary DI / UDI-DI
03700386931789
Basic UDI-DI
08858251027973VK
FDA product code
HWE
EMDN code
P091303 Orthopaedic implant drill bits, single-use
GMDN term
Drilling power tool attachment, basic
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
878.4820
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 220 Millimeter
Outer Diameter — 3 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Drilling power tool attachment, basic

Similar devices

Also classified as Drilling power tool attachment, basic.

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE.

Other devices from Tornier, Inc.

See all devices from Tornier, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)