Skip to content

Neuro System 19-5001

by Biomet Microfixation, Inc

Part of a family of 41 devices: see the family page

Ref 19-5001

Neuro System 19-5001 is a device classified as Class I in the EU and Class II in the US made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 889024AFS2A), cleared under FDA 510(k) K121624 on 12 Oct 2012 and listed in FDA GUDID since 17 Jun 2020 (UDI-DI 00888233007269), active as of 7 Nov 2026. 2 FDA recalls are 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) K121624

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/MDR EUDAMED Number889024AFS2A Basic UDI-DI 00888233007269UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888233007269 UDI-DI Date17 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121624 Date12 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024AFS2A registered 23 Oct 2026 Active
  • FDA 510(k) K121624 decided 12 Oct 2012 Active
  • FDA GUDID UDI-DI 00888233007269 listed 17 Jun 2020 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0137-2016 FDA Class II initiated 6 Aug 2015
    • Terminated Z-0136-2016 FDA Class II initiated 6 Aug 2015

    The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

Timeline

5 dated events

  1. Cleared FDA 510(k) K121624
  2. Recall initiated FDA recalls Z-0137-2016
  3. Recall initiated FDA recalls Z-0136-2016
  4. Listed FDA GUDID 00888233007269
  5. Registered EUDAMED 889024AFS2A

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  • Withdrawn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
Neuro System
Generic name
Device sterilization/disinfection container, reusable
Device name
General Trays
Model / Ref / Catalog
19-5001
Primary DI / UDI-DI
00888233007269
Basic UDI-DI
889024AFS2A
510(k) Number
FDA product code
HBW, GWO, GXR
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Device sterilization/disinfection container, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5360, 882.5320, 882.5250
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Device sterilization/disinfection container, reusable

Cleared under the same submission (K121624)

and 8 more cleared under K121624

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)