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2.0mm System 01-8065

by Biomet Microfixation, Inc

Ref 01-8065

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

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121624

+2 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841036016036 Basic UDI-DI 00841036016036UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036016036 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121624 Date12 Oct 2012DecidedStatusActive

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

4 recalls · 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.

  • 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.

    • Terminated Z-0108-2011 FDA Unclassified (pre-2012) initiated 31 Aug 2010

    Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).

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

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  • Withdrawn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" EUDAMED
"2.0mm" System GUDID
Generic name
Craniofacial fixation plate, non-bioabsorbable, non-customized
Model / Ref / Catalog
01-8065
Primary DI / UDI-DI
00841036016036
Basic UDI-DI
B-00841036016036
510(k) Number
FDA product code
GWO, HBW, GXR, 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
882.5320, 882.5360, 882.5250, 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)

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Cleared under the same submission (K121624)

Show all (12)

Cleared under the same submission (K854886)

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Other devices from Biomet Microfixation, Inc

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number

Other properties (20)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No