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9735468

by Medtronic Sofamor Danek, Inc.

Ref 9735468

9735468 is a device classified as Class I in the EU and Class II in the US made by Medtronic Sofamor Danek, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 0763000B000098893), cleared under FDA 510(k) K140454 on 22 May 2014 and listed in FDA GUDID since 31 Oct 2020 (UDI-DI 00643169723795), 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 MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140454

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 Number0763000B000098893 Basic UDI-DI 00643169723795UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00643169723795 UDI-DI Date31 Oct 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140454 Date22 May 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000098893 registered 30 Oct 2026 Active
  • FDA 510(k) K140454 decided 22 May 2014 Active
  • FDA GUDID UDI-DI 00643169723795 listed 31 Oct 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2363-2023 FDA Class II initiated 12 Jul 2023

    Incorrect Laser Marking - Solera Awl Tip Tap

Timeline

4 dated events

  1. Cleared FDA 510(k) K140454
  2. Listed FDA GUDID 00643169723795
  3. Recall initiated FDA recalls Z-2363-2023
  4. Registered EUDAMED 0763000B000098893

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  • Withdrawn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

Generic name
Bone tap, reusable
Device name
Taps 9735468 Module Set Module and Lid
Model / reference
9735468
Primary DI / UDI-DI
00643169723795
Basic UDI-DI
0763000B000098893
510(k) Number
FDA product code
OLO
EMDN code
L098003 Orthopaedic and traumatological surgery taps, reusable
GMDN term
Bone tap, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4560
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
Този процедурен пакет е предназначен за насочвана с изображения хирургия
GUDID distribution status
In Commercial Distribution

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: Bone tap, reusable

Cleared under the same submission (K140454)

and 8 more cleared under K140454

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE.

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)