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Osteotome

by Synthes GmbH 2 variants

Ref 389.277, 389.276, 03.605.508, 389.125, 389.851Model T LIF Cages Instruments Orthopaedic Osteotomes, MIS Posterior Orthopaedic Osteotomes, P LIF Cages Instruments Orthopaedic Osteotomes

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00158JL Basic UDI-DI Date11 Jul 2025RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Osteotome
Model / Reference
T LIF Cages Instruments Orthopaedic Osteotomes, 389.277, 389.276, MIS Posterior Orthopaedic Osteotomes, 03.605.508, P LIF Cages Instruments Orthopaedic Osteotomes, 389.125, 389.851
Primary DI / UDI-DI
07611819742062, 07611819742055, 07611819317871, 07611819742697, 07611819792333
Basic UDI-DI
7611819a00158JL, 7611819a00196JU, 7611819a00136JA
Direct Marketing DI
07611819742062
07611819742055
07611819317871
07611819742697
07611819792333
EMDN Code
L090401 Orthopaedic surgery osteotomes, reusable
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties

  • Reusable
  • CMR Substance YesEUDAMEDNoEUDAMED

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No