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Ribfix Blu Advantage 323.2008

by Biomet Microfixation, Inc

Ref 323.2008

Ribfix Blu Advantage 323.2008 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 889024-ZB001763-GH), cleared under FDA 510(k) K142823 on 25 Feb 2015 and listed in FDA GUDID since 22 Jul 2021 (UDI-DI 00888233039550), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142823

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 Number889024-ZB001763-GH Basic UDI-DI 00888233039550UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00888233039550 UDI-DI Date22 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142823 Date25 Feb 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB001763-GH registered 23 Oct 2026 Active
  • FDA 510(k) K142823 decided 25 Feb 2015 Active
  • FDA GUDID UDI-DI 00888233039550 listed 22 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142823
  2. Listed FDA GUDID 00888233039550
  3. Registered EUDAMED 889024-ZB001763-GH

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  • Withdrawn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
Ribfix Blu Advantage
Generic name
Surgical implant template, reusable
Device name
RibFix Advantage Instrument
Model / Ref / Catalog
323.2008
Primary DI / UDI-DI
00888233039550
Basic UDI-DI
889024-ZB001763-GH
Direct marketing DI
00888233039550
510(k) Number
FDA product code
HRS
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical implant template, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
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: Surgical implant template, reusable

Cleared under the same submission (K142823)

and 8 more cleared under K142823

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)