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CoLink Afx

by In2Bones, USA 30 variants

Part of a family of 37 devices: see the family page

Ref P07 N1304

CoLink Afx (P07 N1304) is a device classified as Class IIa in the EU and Class II in the US made by In2Bones, USA, registered in EUDAMED on 28 Jan 2026 (Basic UDI-DI 08101755025342), cleared under FDA 510(k) K181113 on 15 Jun 2018 and listed in FDA GUDID since 22 Oct 2018 (UDI-DI 00817906028584), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K181113

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08101755025342 Basic UDI-DI 00817906028584UDI-DIDate28 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817906028584 UDI-DI Date22 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK181113 Date15 Jun 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08101755025342 registered 28 Jan 2026 Active
  • FDA 510(k) K181113 decided 15 Jun 2018 Active
  • FDA GUDID UDI-DI 00817906028584 listed 22 Oct 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K181113
  2. Listed FDA GUDID 00817906028584
  3. Registered EUDAMED 08101755025342

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  • Withdrawn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
Surgical implant/trial-implant/sizer holder, reusable
Device name
Ankle Fracture Non-Sterile Instruments (Trials), Active
Model / Ref / Catalog
P07 N1304
Primary DI / UDI-DI
00817906028584
Basic UDI-DI
08101755025342
510(k) Number
FDA product code
HWC, HRS
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Surgical implant/trial-implant/sizer holder, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Standard device
EU market of registration
Belgium
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.

Manufacturer details

EUDAMED SRN
US-MF-000023092
Authorised representative
Conmed Europe BV BE-AR-000035662

Related devices

Category: Orthopaedic implant impactor, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

Other devices from In2Bones, USA

See all devices from In2Bones, USA →

Properties

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