Skip to content

47-2255-08-01

by Zimmer, Inc.

Ref 47-2255-008-01

47-2255-08-01 (47-2255-008-01) is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00889024581845), cleared under FDA 510(k) K191238 on 5 Jul 2019 and listed in FDA GUDID since 15 Jul 2019 (UDI-DI 00889024581845), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191238

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00889024581845 Basic UDI-DI 00889024581845UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024581845 UDI-DI Date15 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK191238 Date5 Jul 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024581845 registered 30 Oct 2026 Active
  • FDA 510(k) K191238 decided 5 Jul 2019 Active
  • FDA GUDID UDI-DI 00889024581845 listed 15 Jul 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191238
  2. Listed FDA GUDID 00889024581845
  3. Registered EUDAMED B-00889024581845

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Orthopaedic prosthesis implantation positioning instrument, single-use
Device name
D. 3.0 mm 100 cm Length Smooth Ball Tip Guide Wire
Model / Ref / Catalog
47-2255-008-01, 47-2255-08-01
Primary DI / UDI-DI
00889024581845
Basic UDI-DI
B-00889024581845
510(k) Number
FDA product code
HSB
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
888.3020
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 100.00 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
47-2255-008-01
GUDID
47-2255-08-01
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

Cleared under the same submission (K191238)

and 4 more cleared under K191238

Similar devices in this category

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

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)