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Tomofix

by Synthes GmbH 13 variants

Ref 04.120.551, 312.929, 312.924, 395.000, 397.995, 395.001, 440.831S, 04.120.550S, 440.838, 397.993, 440.838S, 395.162, 395.166, 440.853, 397.991, 03.120.068, 04.120.551S, 440.834, 312.926, 440.837S, 440.874, 04.120.550, 440.843S, 397.992, 312.930, 440.843, 312.933, 440.864SModel TomoFix Distal Femur Plate, Orthopaedic Guides, Orthopaedic Bone Forceps, Spreader and Taps with Measuring Features, Orthopaedic Osteotomes, Orthopaedic Drill, Guide and Sleeve with Measuring Features, TomoFix High Tibia Plate, Orthopaedic Retractors

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00471JT Basic UDI-DI Date15 Aug 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  • Withdrawn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
TomoFix Distal Femur Plate
Orthopaedic Guides
Orthopaedic Bone Forceps, Spreader and Taps with Measuring Features
Orthopaedic Osteotomes
Orthopaedic Drill, Guide and Sleeve with Measuring Features
TomoFix High Tibia Plate
Orthopaedic Retractors
Model / Reference
TomoFix Distal Femur Plate, 04.120.551, Orthopaedic Guides, 312.929, 312.924, Orthopaedic Bone Forceps, Spreader and Taps with Measuring Features, 395.000, Orthopaedic Osteotomes, 397.995, Orthopaedic Drill, Guide and Sleeve with Measuring Features, 395.001, TomoFix High Tibia Plate, 440.831S, 04.120.550S, 440.838, 397.993, 440.838S, 395.162, Orthopaedic Retractors, 395.166, 440.853, 397.991, 03.120.068, 04.120.551S, 440.834, 312.926, 440.837S, 440.874, 04.120.550, 440.843S, 397.992, 312.930, 440.843, 312.933, 440.864S
Primary DI / UDI-DI
07611819418745, 07612334079237, 07611819941885, 07611819278721, 07611819275737, 07611819284951, 07611819941908, 07611819427341, 07612334080233, 07611819275713, 07612334080257, 07612334080172, 07612334080219, 07611819282858, 07611819275690, 07611819418707, 07611819427358, 07611819254442, 07611819256118, 07612334080240, 07611819282872, 07611819418738, 07611819245778, 07611819275706, 07611819256125, 07611819282841, 07611819256156, 07611819245792
Basic UDI-DI
7611819a00471JT, 7611819a00094JK, 7611819a00227JE, 7611819a00073JB, 7611819a00229JJ, 7611819a00470JR, 7611819a00462JS
Direct Marketing DI
07612334079237
07611819941885
07611819278721
07611819275737
07611819284951
07611819275713
07612334080172
07612334080219
07611819275690
07611819418707
07611819256118
07611819275706
07611819256125
07611819256156
EMDN Code
P09120501, L091001, V030204, L090402, Z12139099
Device Class
Class IIb
Class I
Class IIa
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

  • Sterile NoEUDAMEDYesEUDAMED
  • Implantable YesEUDAMEDNoEUDAMED
  • Reusable NoEUDAMEDYesEUDAMED
  • Sutures
  • CMR Substance NoEUDAMEDYesEUDAMED
  • Measuring Function NoEUDAMEDYesEUDAMED

Other properties (8)

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