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Instrument 1235-0-461

by Howmedica Osteonics Corp.

Part of a family of 20 devices: see the family page

Ref 1235-0-461Model 08858251005232SW

Instrument 1235-0-461 is a device classified as Class IIa in the EU and Class II in the US made by Howmedica Osteonics Corp., registered in EUDAMED on 14 Sep 2026 (Basic UDI-DI 08858251005232SW) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07613327194098), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251005232SW Basic UDI-DI 07613327194098UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327194098 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251005232SW registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 07613327194098 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327194098
  2. Registered EUDAMED 08858251005232SW

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  • Withdrawn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
Restoration ADM EUDAMED
Instrument GUDID
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Device name
TF-025 - Class IIa - Hip - ADM Cup Trial
Model / Ref / Catalog
1235-0-461, 08858251005232SW
Primary DI / UDI-DI
07613327194098
Basic UDI-DI
08858251005232SW
Direct marketing DI
07613327194098
FDA product code
HWC, KWY, LZO, JDI, MEH, LPH, MAY, KWZ, LWJ, MBL, KWL
EMDN code
V06010101 Hip prostheses testing devices
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3390, 888.3353, 888.3350, 888.3358, 888.3310, 888.3360
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 46.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Acetabulum prosthesis trial, prefabricated, reusable

Similar devices in this category

Other devices filed under HIP PROSTHESES TESTING DEVICES.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)