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Ncb® 02.00024.310

by Zimmer, Inc.

Ncb® 02.00024.310 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K100111 on 12 Apr 2010 and listed in FDA GUDID since 2 Jul 2016 (UDI-DI 00889024081710), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K100111

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024081710 UDI-DI Date2 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100111 Date12 Apr 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100111 decided 12 Apr 2010 Active
  • FDA GUDID UDI-DI 00889024081710 listed 2 Jul 2016 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

4 dated events

  1. Cleared FDA 510(k) K100111
  2. Listed FDA GUDID 00889024081710
  3. Recall initiated FDA recalls Z-0304-2020
  4. Recall initiated FDA recalls Z-0329-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ncb®
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
02.00024.310
Primary DI / UDI-DI
00889024081710
510(k) Number
FDA product code
HRS, HWC
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class II
Regulation number
888.3030, 888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K100111)

and 8 more cleared under K100111

Similar devices in this category

Other devices filed under Orthopaedic prosthesis implantation positioning instrument, reusable.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)