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DOLPHIX SS Bone screw ø6mm L200-45mm

by Citieffe

Ref DF486200Model Bone screws for external fixator (steel)

DOLPHIX SS Bone screw ø6mm L200-45mm (DF486200) is a device classified as Class IIb in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI 803290962006BM), cleared under FDA 510(k) K132363 on 16 Jan 2014 and listed in FDA GUDID since 17 Oct 2018 (UDI-DI 08051739531312), 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) K132363

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 Number803290962006BM Basic UDI-DI 08051739531312UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08051739531312 UDI-DI Date17 Oct 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132363 Date16 Jan 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962006BM registered 9 Oct 2026 Active
  • FDA 510(k) K132363 decided 16 Jan 2014 Active
  • FDA GUDID UDI-DI 08051739531312 listed 17 Oct 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132363
  2. Listed FDA GUDID 08051739531312
  3. Registered EUDAMED 803290962006BM

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  • Withdrawn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
Dolphix® bone screw EUDAMED
Dolphix GUDID
Generic name
External orthopaedic fixation system, single-use, sterile
Device name
Bone screws
Model / Ref / Catalog
Bone screws for external fixator (steel), DF486200, SS Bone screw ø6mm L200-45mm
Primary DI / UDI-DI
08051739531312
Basic UDI-DI
803290962006BM
510(k) Number
FDA product code
JDW, KTT
EMDN code
P09120402 Screws
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

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Bone screws for external fixator (steel)
DF486200
GUDID
SS Bone screw ø6mm L200-45mm
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 (K132363)

and 8 more cleared under K132363

Similar devices in this category

Other devices filed under SCREWS.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Reprocessed single-use device
  • Sutures
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)