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Ncb®-Pp 02.00024.413

by Zimmer, Inc.

Ref 02.00024.413

Ncb®-Pp 02.00024.413 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI 889024N7JA), cleared under FDA 510(k) K241754 on 15 Aug 2024 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00889024289994), active as of 23 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241754

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024N7JA Basic UDI-DI 00889024289994UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241754 Date15 Aug 2024DecidedStatusActive
United StatesGUDID listing GUDID Number00889024289994 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024N7JA registered 19 Oct 2026 Active
  • FDA 510(k) K241754 decided 15 Aug 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024289994 listed 24 Sep 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0338-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K120772
    • Terminated Z-0330-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K120772
  2. Listed FDA GUDID 00889024289994
  3. Recall initiated FDA recalls Z-0338-2020
  4. Recall initiated FDA recalls Z-0330-2020
  5. Cleared FDA 510(k) K241754
  6. Registered EUDAMED 889024N7JA

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Ncb®-Pp
Generic name
General internal orthopaedic fixation system implantation kit
Device name
NCB® PP, trochanter plate, provisional,
Model / Ref / Catalog
02.00024.413
Primary DI / UDI-DI
00889024289994
Basic UDI-DI
889024N7JA
Direct marketing DI
00889024289994
510(k) Number
FDA product code
HRS, HWC
EMDN code
L091099 Osteosynthesis instruments, reusable - other
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3030, 888.3040
EU registration type
Standard device
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: General internal orthopaedic fixation system implantation kit

Cleared under the same submission (K120772)

and 8 more cleared under K120772

Cleared under the same submission (K241754)

and 8 more cleared under K241754

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

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