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Nexel® 00-8401-072-04

by Zimmer, Inc.

Ref 00-8401-072-04

Nexel® 00-8401-072-04 is a device classified as Class IIa in the EU and Class II in the US made by Zimmer, Inc., registered in EUDAMED on 1 Nov 2026 (Basic UDI-DI B-00889024272101), cleared under FDA 510(k) K123862 on 12 Mar 2013 and listed in FDA GUDID since 8 Aug 2016 (UDI-DI 00889024272101), 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) K123862

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-00889024272101 Basic UDI-DI 00889024272101UDI-DIDate1 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00889024272101 UDI-DI Date8 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK123862 Date12 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00889024272101 registered 1 Nov 2026 Active
  • FDA 510(k) K123862 decided 12 Mar 2013 Active
  • FDA GUDID UDI-DI 00889024272101 listed 8 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K123862
  2. Listed FDA GUDID 00889024272101
  3. Registered EUDAMED B-00889024272101

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  • Withdrawn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
Nexel®
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Nexel Flexible Cannulated Reamer
Model / Ref / Catalog
00-8401-072-04
Primary DI / UDI-DI
00889024272101
Basic UDI-DI
B-00889024272101
510(k) Number
FDA product code
JDC
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3150
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 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: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K123862)

and 8 more cleared under K123862

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)