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1.5mm/2.0mm System 01-7164

by Biomet Microfixation, Inc

Ref 01-7164

1.5mm/2.0mm System 01-7164 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 24 Oct 2026 (Basic UDI-DI B-00841036013264), cleared under FDA 510(k) K121589 on 21 Sep 2012 and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036013264), 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-00841036013264 Basic UDI-DI 00841036013264UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036013264 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-00841036013264 registered 24 Oct 2026 Active
  • FDA 510(k) K121589 decided 21 Sep 2012 Active
  • FDA GUDID UDI-DI 00841036013264 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 00841036013264
  3. Recall initiated FDA recalls Z-1220-2017
  4. Registered EUDAMED B-00841036013264

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  • Withdrawn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
1.5mm/2.0mm System
Generic name
Surgical instrument handle, non-torque-limiting
Device name
CranioFacial Instruments
Model / Ref / Catalog
01-7164
Primary DI / UDI-DI
00841036013264
Basic UDI-DI
B-00841036013264
510(k) Number
FDA product code
JEY
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I 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 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 instrument handle, non-torque-limiting

Cleared under the same submission (K121589)

and 8 more cleared under K121589

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
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)