Skip to content

00-5851-032-17

by Zimmer, Inc.

Ref 00-5851-032-17

00-5851-032-17 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00889024196810), cleared under FDA 510(k) K110940 on 1 Jul 2011 and listed in FDA GUDID since 24 May 2016 (UDI-DI 00889024196810), 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) K110940

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-00889024196810 Basic UDI-DI 00889024196810UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024196810 UDI-DI Date24 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK110940 Date1 Jul 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024196810 registered 2 Nov 2026 Active
  • FDA 510(k) K110940 decided 1 Jul 2011 Active
  • FDA GUDID UDI-DI 00889024196810 listed 24 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K110940
  2. Listed FDA GUDID 00889024196810
  3. Registered EUDAMED B-00889024196810

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  • Withdrawn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

Trade name
Tm Hip Flat 7mm Washer Prov
Generic name
Knee femur prosthesis trial, reusable
Device name
Kn Segmental Tissue Washer Prov
Model / reference
00-5851-032-17
Primary DI / UDI-DI
00889024196810
Basic UDI-DI
B-00889024196810
510(k) Number
FDA product code
JDI, LPH, KWY, LZO, KWL, KWZ, LWJ, KRO
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Knee femur prosthesis trial, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3350, 888.3358, 888.3390, 888.3353, 888.3360, 888.3310, 888.3510
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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: Knee femur prosthesis trial, reusable

Cleared under the same submission (K110940)

and 8 more cleared under K110940

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)