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Cervical Distractor Screw

by Synthes GmbH

Ref 396.970, 396.971Model Cervical Distractor Screw

Cervical Distractor Screw (396.970) is a Class IIa device made by Synthes GmbH, registered in EUDAMED on 11 Jul 2025 (Basic UDI-DI 7611819a00455JV), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00455JV Basic UDI-DI Date11 Jul 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Cervical Distractor Screw
Model / reference
Cervical Distractor Screw, 396.970, 396.971
Primary DI / UDI-DI
07611819110045, 07611819110052
Basic UDI-DI
7611819a00455JV
Direct marketing DI
07611819110045
07611819110052
EMDN code
Z12139099 Various orthopaedic and traumatology instruments - other
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

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

Similar devices in this category

Other devices filed under VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS.

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
Other properties (12, all answered No)