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ST.A.R. 90 F4 Knee fixator distractor

by Citieffe

Ref F4-2746Model External fixator

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

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 Number803290962004BH Basic UDI-DI 08051739535730UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051739535730 UDI-DI Date10 Mar 2026ListedStatusListed GUDID: 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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
STAR 90 F4 (Ginocchio) EUDAMED
St.a.r. 90 F4 GUDID
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Device Name
External fixator
Model / Ref / Catalog
External fixator, F4-2746, Knee fixator distractor
Primary DI / UDI-DI
08051739535730
Basic UDI-DI
803290962004BH
510(k) Number
FDA Product Code
JDW, KTT
EMDN Code
P09120499 External bone fixation systems - other
GMDN Term
External orthopaedic fixation system noninvasive component, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3040, 888.3030
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
External fixator
F4-2746
GUDID
Knee fixator distractor
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K113384)

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Properties

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

Other properties (18)

  • Implantable: No
  • 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