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Dolphix

by Citieffe 11 variants

Ref DF206260Model Bone screw for external fixator and kit

Dolphix (DF206260) is a device classified as Class IIb in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 803290962005BK), cleared under FDA 510(k) K163323 on 20 Mar 2017 and listed in FDA GUDID since 20 Mar 2018 (UDI-DI 08032909625130), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163323

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962005BK Basic UDI-DI 08032909625130UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909625130 UDI-DI Date20 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163323 Date20 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962005BK registered 7 Oct 2026 Active
  • FDA 510(k) K163323 decided 20 Mar 2017 Active
  • FDA GUDID UDI-DI 08032909625130 listed 20 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163323
  2. Listed FDA GUDID 08032909625130
  3. Registered EUDAMED 803290962005BK

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vite Ossee Dolphix in Kit EUDAMED
Dolphix GUDID
Generic name
External orthopaedic fixation system, single-use, sterile
Device name
Dolphix Bone Screw in Kit
Model / Ref / Catalog
Bone screw for external fixator and kit, DF206260, Clamp with transfixing bone screw ø6mm L260mm
Primary DI / UDI-DI
08032909625130
Basic UDI-DI
803290962005BK
510(k) Number
FDA product code
JDW, KTT
EMDN code
P09120499 External bone fixation systems - other
GMDN term
External orthopaedic fixation system, single-use, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Bone screw for external fixator and kit
DF206260
GUDID
Clamp with transfixing bone screw ø6mm L260mm
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: External orthopaedic fixation system, single-use, sterile

Cleared under the same submission (K163323)

and 8 more cleared under K163323

Similar devices in this category

Other devices filed under EXTERNAL BONE FIXATION SYSTEMS - OTHER.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Sutures
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)