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Instrument 0930-3-005

by Howmedica Osteonics Corp.

Ref 0930-3-005Model 08858251004920TK

Instrument 0930-3-005 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 21 Oct 2026 (Basic UDI-DI 08858251004920TK) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07613327260960), 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 Number08858251004920TK Basic UDI-DI 07613327260960UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327260960 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004920TK registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 07613327260960 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07613327260960
  2. Registered EUDAMED 08858251004920TK

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  • Withdrawn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
Exeter EUDAMED
Instrument GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, single-use
Device name
TF-030 - Class IIa - Poly Trunnion Protector - Gamma
Model / Ref / Catalog
0930-3-005, 08858251004920TK
Primary DI / UDI-DI
07613327260960
Basic UDI-DI
08858251004920TK
FDA product code
JDI, KWL, MAY, MBL, LPH, LZO, HWC, KWZ, LWJ, MEH, KWY
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3350, 888.3360, 888.3353, 888.3358, 888.3040, 888.3310, 888.3390
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

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: Orthopaedic prosthesis implantation positioning instrument, single-use

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)