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Ncb® 02.02151.010

by Zimmer, Inc.

Ref 02.02151.010

Ncb® 02.02151.010 is a device classified as Class IIb in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 1 Nov 2026 (Basic UDI-DI B-00889024082403), cleared under FDA 510(k) K100111 on 12 Apr 2010 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 00889024082403), 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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K100111

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-00889024082403 Basic UDI-DI 00889024082403UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024082403 UDI-DI Date17 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK100111 Date12 Apr 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024082403 registered 1 Nov 2026 Active
  • FDA 510(k) K100111 decided 12 Apr 2010 Active
  • FDA GUDID UDI-DI 00889024082403 listed 17 Sep 2015 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0304-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K100111
    • Terminated Z-0329-2020 FDA Class II initiated 10 Oct 2019 on shared 510(k) K100111

    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

5 dated events

  1. Cleared FDA 510(k) K100111
  2. Listed FDA GUDID 00889024082403
  3. Recall initiated FDA recalls Z-0304-2020
  4. Recall initiated FDA recalls Z-0329-2020
  5. Registered EUDAMED B-00889024082403

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  • Withdrawn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 bone screw (non-sliding)
Model / Ref / Catalog
02.02151.010
Primary DI / UDI-DI
00889024082403
Basic UDI-DI
B-00889024082403
510(k) Number
FDA product code
HWC
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 10 Millimeter

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: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K100111)

and 8 more cleared under K100111

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)