Piccolo Composite Plate System… PDFLN2003: CE/MDR Class IIb

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number729011020CARBOFIX010UE Basic UDI-DI 07290109334233UDI-DI	Date29 Sep 2026Registered	StatusActive
United States	GUDID listing GUDID	Number07290109334233 UDI-DI	Date15 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK130061	Date27 Feb 2013Decided	StatusActive
United States	FDA 510(k) GUDID from GUDID	NumberK120409	Date26 Nov 2012Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI 729011020CARBOFIX010UE — open Devices and search for it
AccessGUDID record UDI-DI 07290109334233
FDA 510(k) database 510(k) number K130061
FDA 510(k) database 510(k) number K120409

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 07290109334233 listed 15 Oct 2015 Listed

Timeline

4 dated events

26 Nov 2012 Cleared FDA 510(k) K120409
27 Feb 2013 Cleared FDA 510(k) K130061
15 Oct 2015 Listed FDA GUDID 07290109334233
29 Sep 2026 Registered EUDAMED 729011020CARBOFIX010UE

Coverage

2 jurisdictions

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Withdrawn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: PDFLN2003, Distal Fibula Plate

Primary DI / UDI-DI: 07290109334233
Basic UDI-DI: 729011020CARBOFIX010UE
510(k) Number: K120409
K130061
FDA product code: KTT, HRS, HWC
EMDN code: P09120599 Bone fixation plates - other
GMDN term: Orthopaedic fixation plate, non-bioabsorbable

Device class: Class IIb EUDAMED
Class II GUDID
Regulation number: 888.3030, 888.3040
EU registration type: Standard device
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Size: Length — 72 Millimeter

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / reference	EUDAMED PDFLN2003	GUDID Distal Fibula Plate
Device class	EUDAMED 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.