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Angulated awl 265641

by Fournitures Hospitalieres Industrie

Part of a family of 68 devices: see the family page

Ref 265641Model TLS reusable instruments

Angulated awl 265641 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 4 Apr 2024 (Basic UDI-DI 3661489LIGTLSCIRMJZ), cleared under FDA 510(k) K120740 on 5 Mar 2013 (1 earlier submission) and listed in FDA GUDID since 13 Mar 2019 (UDI-DI 03661489656415), 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) K120740

+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 Number3661489LIGTLSCIRMJZ Basic UDI-DI 03661489656415UDI-DIDate4 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number03661489656415 UDI-DI Date13 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK120740 Date5 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 3661489LIGTLSCIRMJZ registered 4 Apr 2024 Active
  • FDA 510(k) K120740 decided 5 Mar 2013 Active· +1 more in the status table
  • FDA GUDID UDI-DI 03661489656415 listed 13 Mar 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K113591
  2. Cleared FDA 510(k) K120740
  3. Listed FDA GUDID 03661489656415
  4. Registered EUDAMED 3661489LIGTLSCIRMJZ

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  • Withdrawn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
Angulated awl
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
TLS reusable instruments
Model / reference
265641, TLS reusable instruments
Primary DI / UDI-DI
03661489656415
Basic UDI-DI
3661489LIGTLSCIRMJZ
Direct marketing DI
03661489656415
510(k) Number
FDA product code
MBI, HWC
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040
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 (K113591)

and 8 more cleared under K113591

Cleared under the same submission (K120740)

and 8 more cleared under K120740

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS 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)