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Piccolo Composite Plate System Distal Fibula Plate

by Carbofix Orthopedics Ltd 12 variants

Ref PDFLN2004

Piccolo Composite Plate System Distal Fibula Plate (PDFLN2004) is a device classified as Class IIb in the EU and Class II in the US made by Carbofix Orthopedics Ltd, registered in EUDAMED on 29 Sep 2026 (Basic UDI-DI 729011020CARBOFIX010UE), cleared under FDA 510(k) K130061 on 27 Feb 2013 (1 earlier submission) and listed in FDA GUDID since 18 Oct 2015 (UDI-DI 07290109334257), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130061

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011020CARBOFIX010UE Basic UDI-DI 07290109334257UDI-DIDate29 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290109334257 UDI-DI Date18 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK130061 Date27 Feb 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729011020CARBOFIX010UE registered 29 Sep 2026 Active
  • FDA 510(k) K130061 decided 27 Feb 2013 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290109334257 listed 18 Oct 2015 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K120409
  2. Cleared FDA 510(k) K130061
  3. Listed FDA GUDID 07290109334257
  4. Registered EUDAMED 729011020CARBOFIX010UE

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  • Withdrawn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
Piccolo Composite ® Distal Fibula Plate EUDAMED
Piccolo Composite Plate System GUDID
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Distal Fibula Plates
Model / Ref / Catalog
PDFLN2004, Distal Fibula Plate
Primary DI / UDI-DI
07290109334257
Basic UDI-DI
729011020CARBOFIX010UE
510(k) Number
FDA product code
HWC, HRS, KTT
EMDN code
P09120599 Bone fixation plates - other
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
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
Size
Length — 85 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PDFLN2004
GUDID
Distal Fibula Plate
Device classEUDAMED
Class IIb
GUDID
Class II

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: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K120409)

and 8 more cleared under K120409

Cleared under the same submission (K130061)

and 8 more cleared under K130061

Similar devices in this category

Other devices filed under BONE FIXATION PLATES.

Other devices from Carbofix Orthopedics Ltd

See all devices from Carbofix Orthopedics Ltd →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)