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Drill Tip 2, 5 Guide 253677

by Fournitures Hospitalieres Industrie

Part of a family of 24 devices: see the family page

Ref 253677

Drill Tip 2, 5 Guide 253677 is a device classified as Class I in the EU and Class II in the US made by Fournitures Hospitalieres Industrie, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 3661489TELEVOCIRMM3), cleared under FDA 510(k) K033510 on 3 Dec 2003 (1 earlier submission) and listed in FDA GUDID since 13 Mar 2019 (UDI-DI 03661489536779), active as of 22 Oct 2026.

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

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K033510

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3661489TELEVOCIRMM3 Basic UDI-DI 03661489536779UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03661489536779 UDI-DI Date13 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK033510 Date3 Dec 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3661489TELEVOCIRMM3 registered 21 May 2026 Active
  • FDA 510(k) K033510 decided 3 Dec 2003 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03661489536779 listed 13 Mar 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K023241
  2. Cleared FDA 510(k) K033510
  3. Listed FDA GUDID 03661489536779
  4. Registered EUDAMED 3661489TELEVOCIRMM3

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  • Withdrawn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

Trade name
Telegraph Evo Drill Tip 2.5 Guide EUDAMED
Drill Tip 2,5 Guide GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
TELEGRAPH EVOLUTION reusable instruments
Model / reference
253677
Primary DI / UDI-DI
03661489536779
Basic UDI-DI
3661489TELEVOCIRMM3
510(k) Number
FDA product code
HSB
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
France
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: Orthopaedic prosthesis implantation positioning instrument, reusable

Cleared under the same submission (K023241)

and 8 more cleared under K023241

Cleared under the same submission (K033510)

and 8 more cleared under K033510

Similar devices in this category

Other devices filed under ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Fournitures Hospitalieres Industrie

See all devices from Fournitures Hospitalieres Industrie →

Properties

  • Sterilise before use
  • Reusable
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)