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CoLink

by In2Bones, USA 9 variants

Ref P04 N0361

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08101755051447 Basic UDI-DI 00810021864969UDI-DIDate29 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810021864969 UDI-DI Date12 Dec 2024ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2880-2018 FDA Class II initiated 16 Jul 2018 on shared 510(k) K163293
    • Terminated Z-2879-2018 FDA Class II initiated 16 Jul 2018 on shared 510(k) K163293

    CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Surgical drill guide, reusable
Device Name
Non-patient-contacting Class I instruments, Non-Active
Model / Ref / Catalog
P04 N0361
Primary DI / UDI-DI
00810021864969, 00810021863887
Basic UDI-DI
08101755051447
510(k) Number
FDA Product Code
FZX
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Surgical drill guide, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Belgium
GUDID distribution status
Not in Commercial Distribution (UDI-DI 00810021864969)
In Commercial Distribution (UDI-DI 00810021863887)
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Manufacturer details

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

Other devices from In2Bones, USA

See all devices from In2Bones, USA →

Properties

  • Reusable
  • Prescription Use
  • Over-the-Counter NoGUDIDYesGUDID
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No