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Lcs Complete 1294-05-515

by Depuy Orthopaedics, Inc.

Ref 1294-05-515Model LCS Complete RP Tibial Insert

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

27 Jul 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a005799N Basic UDI-DI 10603295022107UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295022107 UDI-DI Date24 Mar 2015ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 781841 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    30 Jun 2026
    Expires
    27 Jul 2030
    Reason
    Change approved

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  • Withdrawn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

Trade Name
Lcs EUDAMED
Lcs Complete GUDID
Generic Name
Tibial insert
Device Name
RP Tibial Insert
Model / Ref / Catalog
1294-05-515, LCS Complete RP Tibial Insert, 129405515
Primary DI / UDI-DI
10603295022107
Basic UDI-DI
0603295a005799N
FDA Product Code
NJL
EMDN Code
P090903020201 Bicompartmental primary implant mobile bearing tibial inserts
GMDN Term
Tibial insert
Device Class
Class III
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insert

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Reusable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No