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Tmj System 24-6612

by Biomet Microfixation, Inc

Ref 24-6612

Tmj System 24-6612 is a device classified as Class IIa 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-00841036036652), cleared under FDA 510(k) K062842 on 4 Dec 2006 and listed in FDA GUDID since 17 Sep 2014 (UDI-DI 00841036036652), active as of 7 Nov 2026. One FDA recall is linked to it.

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) K062842

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-00841036036652 Basic UDI-DI 00841036036652UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036036652 UDI-DI Date17 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK062842 Date4 Dec 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841036036652 registered 23 Oct 2026 Active
  • FDA 510(k) K062842 decided 4 Dec 2006 Active
  • FDA GUDID UDI-DI 00841036036652 listed 17 Sep 2014 Listed

Recalls

1 recall · FDA

    • Terminated Z-0538-2010 FDA Unclassified (pre-2012) initiated 6 Nov 2009

    The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).

Timeline

4 dated events

  1. Cleared FDA 510(k) K062842
  2. Recall initiated FDA recalls Z-0538-2010
  3. Listed FDA GUDID 00841036036652
  4. Registered EUDAMED B-00841036036652

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  • Withdrawn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
Tmj System
Generic name
Fluted surgical drill bit, reusable
Device name
Twist Drills
Model / Ref / Catalog
24-6612
Primary DI / UDI-DI
00841036036652
Basic UDI-DI
B-00841036036652
510(k) Number
FDA product code
HBE
EMDN code
P091304 Cranial perforators, single-use
GMDN term
Fluted surgical drill bit, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
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 IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Fluted surgical drill bit, reusable

Cleared under the same submission (K062842)

and 8 more cleared under K062842

Similar devices in this category

Other devices filed under CRANIAL PERFORATORS, SINGLE-USE.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

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