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Ncb® 02.03264.115

by Zimmer, Inc.

Ref 02.03264.115

Ncb® 02.03264.115 is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-00889024297623), cleared under FDA 510(k) K241754 on 15 Aug 2024 (1 earlier submission) and listed in FDA GUDID since 20 Oct 2015 (UDI-DI 00889024297623), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

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 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/MDD EUDAMED NumberB-00889024297623 Basic UDI-DI 00889024297623UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241754 Date15 Aug 2024DecidedStatusActive
United StatesGUDID listing GUDID Number00889024297623 UDI-DI Date20 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024297623 registered 19 Oct 2026 Active
  • FDA 510(k) K241754 decided 15 Aug 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024297623 listed 20 Oct 2015 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0304-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0329-2020 FDA Class II initiated 10 Oct 2019

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K100111
  2. Listed FDA GUDID 00889024297623
  3. Recall initiated FDA recalls Z-0304-2020
  4. Recall initiated FDA recalls Z-0329-2020
  5. Cleared FDA 510(k) K241754
  6. Registered EUDAMED B-00889024297623

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  • Withdrawn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
Ncb®
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
NCB® Periprosthetic Distal Femur Plate, Non-Sterile
Model / Ref / Catalog
02.03264.115
Primary DI / UDI-DI
00889024297623
Basic UDI-DI
B-00889024297623
510(k) Number
FDA product code
HWC, HRS
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
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
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K100111)

and 8 more cleared under K100111

Cleared under the same submission (K241754)

and 8 more cleared under K241754

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)