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00-5851-000-12

by Zimmer, Inc.

Ref 00-5851-000-12

00-5851-000-12 is a device classified as Class I in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00889024196384), cleared under FDA 510(k) K110940 on 1 Jul 2011 and listed in FDA GUDID since 26 May 2016 (UDI-DI 00889024196384), 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-00889024196384 Basic UDI-DI 00889024196384UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024196384 UDI-DI Date26 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-00889024196384 registered 2 Nov 2026 Active
  • FDA 510(k) K110940 decided 1 Jul 2011 Active
  • FDA GUDID UDI-DI 00889024196384 listed 26 May 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K110940
  2. Listed FDA GUDID 00889024196384
  3. Registered EUDAMED B-00889024196384

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  • Withdrawn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
Seg Tibia Impactor Size 1-2
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Kn Segmental Tib Impactor Inst
Model / reference
00-5851-000-12
Primary DI / UDI-DI
00889024196384
Basic UDI-DI
B-00889024196384
510(k) Number
FDA product code
KRO, KWY, KWL, KWZ, LWJ, LPH, JDI, LZO
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3510, 888.3390, 888.3360, 888.3310, 888.3358, 888.3350, 888.3353
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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, reusable

Cleared under the same submission (K110940)

and 8 more cleared under K110940

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

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)