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2.0mm System Plate 01-9229

by Biomet Microfixation, Inc

Ref 01-9229

2.0mm System Plate 01-9229 is a device classified as Class IIb in the EU and Class II in the US made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00841036017163), cleared under FDA 510(k) K121589 on 21 Sep 2012 and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036017163), 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121589

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-00841036017163 Basic UDI-DI 00841036017163UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036017163 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK121589 Date21 Sep 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841036017163 registered 23 Oct 2026 Active
  • FDA 510(k) K121589 decided 21 Sep 2012 Active
  • FDA GUDID UDI-DI 00841036017163 listed 11 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1220-2017 FDA Class II initiated 10 Jan 2017 on shared 510(k) K121589

    The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K121589
  2. Listed FDA GUDID 00841036017163
  3. Recall initiated FDA recalls Z-1220-2017
  4. Registered EUDAMED B-00841036017163

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  • Withdrawn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
"""2.0mm"" System Plate" EUDAMED
"2.0mm" System Plate GUDID
Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog
01-9229
Primary DI / UDI-DI
00841036017163
Basic UDI-DI
B-00841036017163
510(k) Number
FDA product code
JEY
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Craniofacial fixation plate, non-bioabsorbable, non-customized
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4760
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 IIb
GUDID
Class II

Related devices

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

Cleared under the same submission (K121589)

and 8 more cleared under K121589

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)